A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

• ClinicalTrials.gov Identifier: NCT00220337
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: July 24, 2023
• Last Update Posted: July 24, 2023
• Sponsor: UCB Pharma
• Collaborator: SCHWARZ BIOSCIENCES GmbH - Part of UCB Group
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Painful Diabetic Neuropathy
• Intervention: Drug: Lacosamide
• Enrollment: 371

Participant Flow

Recruitment Details	The study started to enroll patients in December 2004 and concluded in October 2007.
Pre-assignment Details	Participant Flow refers to the Safety Set.

Arm/Group Title	Lacosamide
Arm/Group Description	Subjects received lacosamide 100 mg (milligrams)/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Period Title: Overall Study
Started	371
Completed	192
Not Completed	179
Reason Not Completed
Adverse Event	70
Lack of Efficacy	17
Withdrawal by Subject	68
Protocol Violation	2
Lost to Follow-up	5
Other	12
Unsatisfactory compliance	5

Baseline Characteristics

Arm/Group Title		Lacosamide
Arm/Group Description		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Baseline Participants		371
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Set which consisted of all subjects who received at least 1 dose of study medication.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	371 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	262 70.6%
	>=65 years	109 29.4%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	371 participants
		58.6 (9.99)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	371 participants
	Female	181 48.8%
	Male	190 51.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator
Description	An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame	From Screening until Safety Follow up Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	371
Measure Type: Number; Unit of Measure: percentage of participants
	80.9

2. Primary Outcome

Title	Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period
Description	Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)
Time Frame	During the titration period (up to Week 8)

Outcome Measure Data

Analysis Population Description

Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Measure Type: Number; Unit of Measure: percentage of participants
Hematocrit	Number Analyzed	362 participants
		0.8
Hemoglobin	Number Analyzed	367 participants
		0.5
White Blood Cell	Number Analyzed	366 participants
		1.4
Basophils	Number Analyzed	364 participants
		1.1
Eosinophils	Number Analyzed	363 participants
		0
Monocytes	Number Analyzed	366 participants
		0
Platelet Count	Number Analyzed	361 participants
		1.1

3. Primary Outcome

Title	Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period
Description	Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)
Time Frame	During the maintenance period (up to 136 weeks)

Outcome Measure Data

Analysis Population Description

Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Measure Type: Number; Unit of Measure: percentage of participants
Hematocrit	Number Analyzed	321 participants
		6.2
Hemoglobin	Number Analyzed	326 participants
		5.5
WBC Count	Number Analyzed	325 participants
		2.8
Basophils	Number Analyzed	324 participants
		2.8
Eosinophils	Number Analyzed	322 participants
		2.8
Monocytes	Number Analyzed	325 participants
		0.3
Platelet Count	Number Analyzed	320 participants
		4.4

4. Primary Outcome

Title	Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period
Description	Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)
Time Frame	During the titration period (up to Week 8)

Outcome Measure Data

Analysis Population Description

Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Measure Type: Number; Unit of Measure: percentage of participants
ALT 3xULN	Number Analyzed	368 participants
		0.5
ALT 5xULN	Number Analyzed	368 participants
		0
ALT 10xULN	Number Analyzed	368 participants
		0
AST 3xULN	Number Analyzed	368 participants
		0
AST 5xULN	Number Analyzed	368 participants
		0
AST 10xULN	Number Analyzed	368 participants
		0
Alkaline Phosphatase	Number Analyzed	368 participants
		0
GGT 3xULN	Number Analyzed	356 participants
		0.6
Total Bilirubin	Number Analyzed	367 participants
		0.5
Albumin	Number Analyzed	368 participants
		0
Blood Urea Nitrogen	Number Analyzed	368 participants
		0.8
Creatinine	Number Analyzed	368 participants
		0
Calcium	Number Analyzed	362 participants
		1.7
Chloride	Number Analyzed	363 participants
		0.3
Phosphorus	Number Analyzed	366 participants
		1.4
Potassium	Number Analyzed	364 participants
		0.3
Sodium	Number Analyzed	368 participants
		0
Glucose	Number Analyzed	212 participants
		40.6
Total Cholesterol	Number Analyzed	31 participants
		3.2
Uric Acid	Number Analyzed	361 participants
		1.1

5. Primary Outcome

Title	Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period
Description	Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)
Time Frame	During the maintenance period (up to 136 weeks)

Outcome Measure Data

Analysis Population Description

Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Measure Type: Number; Unit of Measure: percentage of participants
ALT 3xULN	Number Analyzed	328 participants
		0.6
ALT 5xULN	Number Analyzed	328 participants
		0.3
ALT 10xULN	Number Analyzed	328 participants
		0
AST 3xULN	Number Analyzed	328 participants
		0
AST 5xULN	Number Analyzed	328 participants
		0
AST 10xULN	Number Analyzed	328 participants
		0
Alkaline Phosphatase	Number Analyzed	328 participants
		0.3
GGT 3xULN	Number Analyzed	319 participants
		4.7
Total Bilirubin	Number Analyzed	327 participants
		0.3
Albumin	Number Analyzed	328 participants
		0.3
Blood Urea Nitrogen	Number Analyzed	328 participants
		2.1
Creatinine	Number Analyzed	328 participants
		0.6
Calcium	Number Analyzed	323 participants
		2.5
Chloride	Number Analyzed	323 participants
		3.4
Phosphorus	Number Analyzed	326 participants
		3.4
Potassium	Number Analyzed	325 participants
		2.8
Sodium	Number Analyzed	328 participants
		0
Glucose	Number Analyzed	193 participants
		66.8
Total Cholesterol	Number Analyzed	280 participants
		0.7
Uric Acid	Number Analyzed	323 participants
		1.5

6. Primary Outcome

Title	Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine pH= 5.0 at baseline are included in this analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	239
Measure Type: Number; Unit of Measure: Participants
pH= 5.0	194
pH= 6.0	35
pH= 6.5	2
pH= 7.0	3
pH= 7.5	1
pH= 8.0	0
pH= 8.5	0
not done	4

7. Primary Outcome

Title	Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine pH= 6.0 at baseline are included in this analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	93
Measure Type: Number; Unit of Measure: Participants
pH= 5.0	52
pH= 6.0	31
pH= 6.5	4
pH= 7.0	2
pH= 7.5	1
pH= 8.0	1
pH= 8.5	0
not done	2

8. Primary Outcome

Title	Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine pH= 6.5 at baseline are included in this analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	24
Measure Type: Number; Unit of Measure: Participants
pH= 5.0	10
pH= 6.0	7
pH= 6.5	5
pH= 7.0	0
pH= 7.5	0
pH= 8.0	1
pH= 8.5	0
not done	1

9. Primary Outcome

Title	Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine pH= 7.0 at baseline are included in this analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	8
Measure Type: Number; Unit of Measure: Participants
pH= 5.0	4
pH= 6.0	3
pH= 6.5	1
pH= 7.0	0
pH= 7.5	0
pH= 8.0	0
pH= 8.5	0
not done	0

10. Primary Outcome

Title	Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine pH= 7.5 at baseline are included in this analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: Participants
pH= 5.0	3
pH= 6.0	0
pH= 6.5	3
pH= 7.0	0
pH= 7.5	0
pH= 8.0	0
pH= 8.5	0
not done	0

11. Primary Outcome

Title	Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine pH= 8.0 at baseline are included in this analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: Participants
pH= 5.0	0
pH= 6.0	0
pH= 6.5	1
pH= 7.0	0
pH= 7.5	0
pH= 8.0	0
pH= 8.5	0
not done	0

12. Primary Outcome

Title	Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine White Blood Cell Count 'Negative' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	344
Measure Type: Number; Unit of Measure: Participants
negative	321
trace	7
positive +	3
positive ++	5
positive +++	1
not done	7

13. Primary Outcome

Title	Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine White Blood Cell Count 'Trace' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	15
Measure Type: Number; Unit of Measure: Participants
negative	13
trace	1
positive +	0
positive ++	0
positive +++	1
not done	0

14. Primary Outcome

Title	Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine White Blood Cell Count 'Positive +' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: Participants
negative	3
trace	2
positive +	0
positive ++	1
positive +++	0
not done	0

15. Primary Outcome

Title	Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with urine White Blood Cell Count 'Positive ++' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: Participants
negative	3
trace	0
positive +	2
positive ++	1
positive +++	0
not done	0

16. Primary Outcome

Title	Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Nitrite status 'Negative' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	365
Measure Type: Number; Unit of Measure: Participants
negative	353
positive	5
not done	7

17. Primary Outcome

Title	Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Nitrite status 'Positive' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: Participants
negative	3
positive	3
not done	0

18. Primary Outcome

Title	Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Description	Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Urobilinogen value 3 µmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	361
Measure Type: Number; Unit of Measure: Participants
3 µmol/l	351
16 µmol/l	3
33 µmol/l	0
66 µmol/l	0
Not done	7

19. Primary Outcome

Title	Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Description	Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Urobilinogen value 16 µmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	9
Measure Type: Number; Unit of Measure: Participants
3 µmol/l	7
16 µmol/l	1
33 µmol/l	1
66 µmol/l	0
Not done	0

20. Primary Outcome

Title	Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Description	Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Urobilinogen value 66 µmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: Participants
3 µmol/l	1
16 µmol/l	0
33 µmol/l	0
66 µmol/l	0
Not done	0

21. Primary Outcome

Title	Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Protein status 'Negative' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	317
Measure Type: Number; Unit of Measure: Participants
Negative	292
Trace	13
Positive +	3
Positive ++	1
Positive +++	2
Not done	6

22. Primary Outcome

Title	Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Protein status 'Trace' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	39
Measure Type: Number; Unit of Measure: Participants
Negative	27
Trace	7
Positive +	4
Positive ++	0
Positive +++	0
Not done	1

23. Primary Outcome

Title	Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Protein status 'Positive +' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	7
Measure Type: Number; Unit of Measure: Participants
Negative	3
Trace	1
Positive +	1
Positive ++	2
Positive +++	0
Not done	0

24. Primary Outcome

Title	Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Protein status 'Positive ++' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: Participants
Negative	2
Trace	0
Positive +	3
Positive ++	0
Positive +++	1
Not done	0

25. Primary Outcome

Title	Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Blood status 'Negative' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	345
Measure Type: Number; Unit of Measure: Participants
Negative	319
Trace (N)	7
Trace (H)	1
Positive +	3
Positive ++	4
Positive +++	4
Not done	7

26. Primary Outcome

Title	Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Blood status 'Trace (N)' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	17
Measure Type: Number; Unit of Measure: Participants
Negative	14
Trace (N)	2
Trace (H)	0
Positive +	1
Positive ++	0
Positive +++	0
Not done	0

27. Primary Outcome

Title	Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Blood status 'Trace (H)' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: Participants
Negative	4
Trace (N)	2
Trace (H)	0
Positive +	0
Positive ++	0
Positive +++	0
Not done	0

28. Primary Outcome

Title	Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Blood status 'Positive +' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: Participants
Negative	1
Trace (N)	0
Trace (H)	0
Positive +	0
Positive ++	0
Positive +++	0
Not done	0

29. Primary Outcome

Title	Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Blood status 'Positive ++' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	2
Measure Type: Number; Unit of Measure: Participants
Negative	1
Trace (N)	1
Trace (H)	0
Positive +	0
Positive ++	0
Positive +++	0
Not done	0

30. Primary Outcome

Title	Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Ketone status 'Negative' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	344
Measure Type: Number; Unit of Measure: Participants
Negative	328
Trace	8
Small	1
Moderate	0
Not done	7

31. Primary Outcome

Title	Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Ketone status 'Trace' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	21
Measure Type: Number; Unit of Measure: Participants
Negative	19
Trace	0
Small	2
Moderate	0
Not Done	0

32. Primary Outcome

Title	Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Ketone status 'Small' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	4
Measure Type: Number; Unit of Measure: Participants
Negative	2
Trace	2
Small	0
Moderate	0
Not Done	0

33. Primary Outcome

Title	Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Ketone status 'Moderate' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	2
Measure Type: Number; Unit of Measure: Participants
Negative	2
Trace	0
Small	0
Moderate	0
Not Done	0

34. Primary Outcome

Title	Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Bilirubin status 'Negative' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	360
Measure Type: Number; Unit of Measure: Participants
Negative	351
Positive +	2
Positive ++	0
Not done	7

35. Primary Outcome

Title	Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Bilirubin status 'Positive +' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	8
Measure Type: Number; Unit of Measure: Participants
Negative	8
Positive +	0
Positive ++	0
Not done	0

36. Primary Outcome

Title	Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Bilirubin status 'Positive ++' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	3
Measure Type: Number; Unit of Measure: Participants
Negative	3
Positive +	0
Positive ++	0
Not done	0

37. Primary Outcome

Title	Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit
Description	Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Glucose value 'Negative' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	266
Measure Type: Number; Unit of Measure: Participants
Negative	194
5.5 mmol/l	30
14 mmol/l	16
28 mmol/l	12
55 mmol/l	4
>=111 mmol	6
Not Done	4

38. Primary Outcome

Title	Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Description	Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Glucose value 5.5 mmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	37
Measure Type: Number; Unit of Measure: Participants
Negative	18
5.5 mmol/l	15
14 mmol/l	2
28 mmol/l	1
55 mmol/l	0
>=111 mmol	0
Not Done	1

39. Primary Outcome

Title	Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Description	Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Glucose value 14 mmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	18
Measure Type: Number; Unit of Measure: Participants
Negative	6
5.5 mmol/l	8
14 mmol/l	0
28 mmol/l	1
55 mmol/l	2
>=111 mmol	0
Not Done	1

40. Primary Outcome

Title	Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Description	Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Glucose value 28 mmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	20
Measure Type: Number; Unit of Measure: Participants
Negative	10
5.5 mmol/l	3
14 mmol/l	3
28 mmol/l	3
55 mmol/l	0
>=111 mmol	1
Not Done	0

41. Primary Outcome

Title	Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Description	Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Glucose value 55 mmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	19
Measure Type: Number; Unit of Measure: Participants
Negative	5
5.5 mmol/l	5
14 mmol/l	1
28 mmol/l	3
55 mmol/l	1
>=111 mmol	4
Not Done	0

42. Primary Outcome

Title	Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Description	Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Time Frame	Baseline, Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Glucose value >=111 mmol/l at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	11
Measure Type: Number; Unit of Measure: Participants
Negative	3
5.5 mmol/l	2
14 mmol/l	0
28 mmol/l	2
55 mmol/l	2
>=111 mmol	1
Not Done	1

43. Primary Outcome

Title	Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment
Description	Changes in vital signs examination findings is reported as percentage of subjects with marked abnormalities in - Systolic Blood Pressure (SBP) >=180 mmHg and increase of >=20 mmHg - Systolic Blood Pressure >=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure (DBP) >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure >=50 mmHg and decrease of >=15 mmHg - Pulse Rate (PR) >=120 beats/min and increase of >=15 beats/min - Pulse Rate >=50 beats/min and decrease of >=15 beats/min
Time Frame	During study period (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	371
Measure Type: Number; Unit of Measure: percentage of participants
SBP >=180 and increase of >=20 mmHg	7.5
SBP <=90 and decrease of >=20 mmHg	0.3
DBP >=105 and increase of >=15 mmHg	3.5
DBP <=50 and decrease of >=15 mmHg	0.8
PR >=120 and increase of >=15 beats/min	0.3
PR <=50 and decrease of >=15 beats/min	0.8

44. Primary Outcome

Title	Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment.
Description	Changes in physical examination findings is reported as percentage of subjects with marked abnormalities in following categories: - Ears, Eyes, Nose, Mouth, Throat - Cardiovascular - Peripheral vascular - Pulmonary - Musculoskeletal - Hepato- / Gastrointestinal - Renal / Genitourological - Neurological - Metabolic / Endocrine - Psychiatric - Hematological / Lymphatic Nodes - Dermatological - Other The percentages are based on the number of subjects with examinations done at each visit for each body system.
Time Frame	Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

371 subjects were included in the safety set. Here, Number analyzed signifies those subjects who were evaluable for prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Measure Type: Number; Unit of Measure: percentage of participants
Ears, Eyes, Nose, Mouth, Throat	Number Analyzed	329 participants
		12.2
Cardiovascular	Number Analyzed	330 participants
		15.2
Peripheral vascular	Number Analyzed	330 participants
		14.2
Pulmonary	Number Analyzed	329 participants
		2.1
Musculoskeletal	Number Analyzed	330 participants
		13.3
Hepato- / Gastrointestinal	Number Analyzed	324 participants
		5.2
Renal / Genitourological	Number Analyzed	317 participants
		1.3
Neurological	Number Analyzed	323 participants
		49.5
Metabolic / Endocrine	Number Analyzed	323 participants
		19.5
Psychiatric	Number Analyzed	329 participants
		1.5
Hematological / Lymphatic Nodes	Number Analyzed	327 participants
		0.6
Dermatological	Number Analyzed	329 participants
		16.7
Other	Number Analyzed	15 participants
		93.3

45. Primary Outcome

Title	Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment
Description	Changes in neurological examination findings is reported as percentage of subjects with marked abnormalities in following categories: - General - Cranial Nerves - Reflexes - Muscle Strength and Tone - Coordination and Cerebellar Function - Motor System - Sensation: Upper Extremities - Sensation: Lower Extremities The percentages are based on the number of subjects with examinations done at last visit for each category or parameter.
Time Frame	Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

371 subjects were included in the safety set. Here, Number analyzed signifies those subjects who were evaluable for prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Measure Type: Number; Unit of Measure: percentage of participants
General	Number Analyzed	329 participants
		3.6
Cranial Nerves	Number Analyzed	329 participants
		13.4
Reflexes	Number Analyzed	326 participants
		69.9
Muscle Strength and Tone	Number Analyzed	328 participants
		13.4
Coordination and Cerebellar Function	Number Analyzed	328 participants
		7.0
Motor System	Number Analyzed	323 participants
		3.7
Sensation: Upper Extremities	Number Analyzed	327 participants
		21.1
Sensation: Lower Extremities	Number Analyzed	328 participants
		87.5

46. Primary Outcome

Title	Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings
Description	Changes in 12-lead ECGs is reported as percentage of subjects with abnormal ECG findings categorized in 'Abnormal, possibly insignificant' and 'Abnormal, possibly significant' based on the alert criterion by the ECG vendor and not on the investigator's assessment.
Time Frame	Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with a last visit assessment who had a normal assessment at Baseline where Baseline is defined as the last ECG assessment prior to the first dose of trial medication are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: percentage of participants
Abnormal, possibly insignificant	4.7
Abnormal, possibly significant	18.0

47. Primary Outcome

Title	Percentage of Subjects Who Withdrew Due to Adverse Events (AEs)
Description	An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame	During the study period (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

The Safety Set was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	371
Measure Type: Number; Unit of Measure: percentage of participants
	16.4

48. Primary Outcome

Title	Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit
Description	Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Time Frame	Last Visit (up to 140 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with Urine Protein status 'Positive +++' at baseline are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	2
Measure Type: Number; Unit of Measure: Participants
Negative	0
Trace	0
Positive +	0
Positive ++	1
Positive +++	1
Not done	0

49. Secondary Outcome

Title	Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit
Description	Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.
Time Frame	Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety set. Only subjects with available data for Pain Interference with sleep at the respective visit are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for each visit.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Visit 2.1	Number Analyzed	368 participants
		-0.99 (1.614)
Visit 2.2	Number Analyzed	230 participants
		-1.35 (1.939)
Visit 2.3	Number Analyzed	107 participants
		-1.77 (1.916)
Visit 2.4	Number Analyzed	10 participants
		-1.25 (1.218)
Visit 2.5	Number Analyzed	3 participants
		-1.38 (1.003)
Visit 3	Number Analyzed	331 participants
		-2.62 (2.166)
Visit 4	Number Analyzed	330 participants
		-3.05 (2.313)
Visit 5	Number Analyzed	315 participants
		-3.29 (2.311)
Visit 6	Number Analyzed	308 participants
		-3.27 (2.269)
Visit 7	Number Analyzed	299 participants
		-3.37 (2.307)
Visit 8	Number Analyzed	290 participants
		-3.45 (2.273)
Visit 9.0	Number Analyzed	288 participants
		-3.51 (2.328)
Visit 9.1	Number Analyzed	274 participants
		-3.44 (2.256)
Visit 9.2	Number Analyzed	254 participants
		-3.45 (2.229)
Visit 9.3	Number Analyzed	242 participants
		-3.65 (2.154)
Visit 9.4	Number Analyzed	233 participants
		-3.56 (2.130)
Visit 9.5	Number Analyzed	220 participants
		-3.60 (2.130)
Visit 9.6	Number Analyzed	209 participants
		-3.47 (2.247)
Visit 9.7	Number Analyzed	197 participants
		-3.54 (2.185)
Visit 9.8	Number Analyzed	181 participants
		-3.62 (2.124)
Visit 9.9	Number Analyzed	46 participants
		-3.35 (1.875)

50. Secondary Outcome

Title	Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit
Description	Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.
Time Frame	Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety set. Only subjects with available data for Pain Interference with general activity at the respective visit are included in the analysis. Here, Number analyzed signifies those subjects who were who were evaluable for each visit.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Visit 2.1	Number Analyzed	366 participants
		-0.99 (1.571)
Visit 2.2	Number Analyzed	228 participants
		-1.38 (1.827)
Visit 2.3	Number Analyzed	106 participants
		-1.66 (1.962)
Visit 2.4	Number Analyzed	10 participants
		-1.21 (1.279)
Visit 2.5	Number Analyzed	3 participants
		-1.62 (0.951)
Visit 3	Number Analyzed	331 participants
		-2.56 (2.130)
Visit 4	Number Analyzed	330 participants
		-2.97 (2.273)
Visit 5	Number Analyzed	313 participants
		-3.14 (2.292)
Visit 6	Number Analyzed	308 participants
		-3.17 (2.291)
Visit 7	Number Analyzed	297 participants
		-3.27 (2.321)
Visit 8	Number Analyzed	290 participants
		-3.32 (2.317)
Visit 9.0	Number Analyzed	288 participants
		-3.45 (2.307)
Visit 9.1	Number Analyzed	270 participants
		-3.52 (2.221)
Visit 9.2	Number Analyzed	252 participants
		-3.50 (2.123)
Visit 9.3	Number Analyzed	242 participants
		-3.62 (2.177)
Visit 9.4	Number Analyzed	232 participants
		-3.60 (2.129)
Visit 9.5	Number Analyzed	217 participants
		-3.65 (2.116)
Visit 9.6	Number Analyzed	208 participants
		-3.50 (2.263)
Visit 9.7	Number Analyzed	196 participants
		-3.53 (2.189)
Visit 9.8	Number Analyzed	180 participants
		-3.66 (2.158)
Visit 9.9	Number Analyzed	46 participants
		-3.56 (1.703)

51. Secondary Outcome

Title	Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS)
Description	A 100 mm visual analogue scale (VAS) was used to assess the subject's current pain. The subject rated their current pain from 0 (no pain) to 100 (worst possible pain). A negative value indicates improvement in symptoms.
Time Frame	Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety set. Only subjects with available data for current pain measured by a 100 mm visual analogue scale (VAS) at the respective visit are included in the analysis. Here, Number of subjects analyzed signifies those subjects who were evaluable for each visit.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Visit 2.1	Number Analyzed	365 participants
		-12.32 (19.671)
Visit 2.2	Number Analyzed	225 participants
		-20.79 (23.955)
Visit 2.3	Number Analyzed	107 participants
		-27.87 (23.218)
Visit 2.4	Number Analyzed	10 participants
		-14.80 (14.148)
Visit 2.5	Number Analyzed	3 participants
		-20.33 (14.742)
Visit 3	Number Analyzed	328 participants
		-35.23 (24.986)
Visit 4	Number Analyzed	325 participants
		-37.01 (24.952)
Visit 5	Number Analyzed	312 participants
		-37.91 (24.446)
Visit 6	Number Analyzed	302 participants
		-37.71 (24.269)
Visit 7	Number Analyzed	297 participants
		-40.06 (23.653)
Visit 8	Number Analyzed	290 participants
		-40.25 (23.433)
Visit 9.0	Number Analyzed	287 participants
		-40.24 (23.739)
Visit 9.1	Number Analyzed	275 participants
		-41.47 (22.797)
Visit 9.2	Number Analyzed	261 participants
		-40.08 (24.447)
Visit 9.3	Number Analyzed	245 participants
		-41.56 (24.140)
Visit 9.4	Number Analyzed	234 participants
		-41.00 (22.533)
Visit 9.5	Number Analyzed	224 participants
		-41.45 (23.199)
Visit 9.6	Number Analyzed	211 participants
		-40.88 (24.142)
Visit 9.7	Number Analyzed	197 participants
		-41.69 (23.089)
Visit 9.8	Number Analyzed	181 participants
		-41.83 (23.278)
Visit 9.9	Number Analyzed	49 participants
		-43.63 (21.543)

52. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 4

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	317
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	0
Mildly Worse	0.9
No Change	6.0
Mildly Better	27.1
Moderately Better	32.5
Much Better	33.4

53. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 6

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	299
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	0
Mildly Worse	2
No Change	8.4
Mildly Better	23.7
Moderately Better	34.8
Much Better	31.1

54. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.0

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	277
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	0.7
Mildly Worse	1.4
No Change	6.1
Mildly Better	18.8
Moderately Better	35.7
Much Better	37.2

55. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.1

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	269
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0.7
Moderately Worse	0.4
Mildly Worse	2.6
No Change	5.6
Mildly Better	18.2
Moderately Better	37.2
Much Better	35.3

56. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.2

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	249
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0.4
Moderately Worse	0.8
Mildly Worse	4.0
No Change	4.4
Mildly Better	17.3
Moderately Better	34.5
Much Better	38.6

57. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.3

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	237
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	1.3
Mildly Worse	3.0
No Change	4.2
Mildly Better	20.7
Moderately Better	34.6
Much Better	36.3

58. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.4

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	226
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	0.9
Mildly Worse	4.4
No Change	5.8
Mildly Better	18.6
Moderately Better	35.0
Much Better	35.4

59. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.5

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	212
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	1.9
Mildly Worse	3.3
No Change	6.6
Mildly Better	18.4
Moderately Better	34.4
Much Better	35.4

60. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.6

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	202
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	3.0
Mildly Worse	1.5
No Change	7.9
Mildly Better	19.3
Moderately Better	31.2
Much Better	37.1

61. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.7

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	184
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0.5
Moderately Worse	2.2
Mildly Worse	3.8
No Change	6.0
Mildly Better	20.1
Moderately Better	31.5
Much Better	35.9

62. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Visit 9.8

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	49
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0
Moderately Worse	2.0
Mildly Worse	4.1
No Change	8.2
Mildly Better	10.2
Moderately Better	36.7
Much Better	38.8

63. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit
Description	The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Time Frame	Termination Visit (last treatment visit)

Outcome Measure Data

Analysis Population Description

Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	329
Measure Type: Number; Unit of Measure: percentage of participants
Much Worse	0.9
Moderately Worse	2.4
Mildly Worse	3.6
No Change	13.4
Mildly Better	20.4
Moderately Better	28.6
Much Better	30.7

64. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the Neuropathic Pain Symptoms Inventory (NPSI) at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 4

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	Number Analyzed	109 participants
		-3.1 (3.00)
Squeezing	Number Analyzed	109 participants
		-1.5 (3.53)
Pressure	Number Analyzed	108 participants
		-2.6 (3.47)
Electric shocks	Number Analyzed	109 participants
		-2.3 (3.41)
Stabbing	Number Analyzed	109 participants
		-2.6 (3.56)
Brushing	Number Analyzed	109 participants
		-1.0 (2.90)
Increased by pressure	Number Analyzed	109 participants
		-1.9 (3.49)
Contact with cold	Number Analyzed	109 participants
		-1.4 (2.51)
Pins and needles	Number Analyzed	109 participants
		-2.7 (3.36)
Tingling	Number Analyzed	109 participants
		-2.3 (3.58)

65. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 6

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	102
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-2.9 (3.28)
Squeezing	-1.7 (3.35)
Pressure	-2.5 (3.10)
Electric shocks	-2.5 (3.20)
Stabbing	-2.6 (3.18)
Brushing	-1.2 (3.12)
Increased by pressure	-1.8 (3.36)
Contact with cold	-1.2 (2.90)
Pins and needles	-3.3 (2.89)
Tingling	-2.9 (3.58)

66. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.0

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	Number Analyzed	88 participants
		-3.0 (2.78)
Squeezing	Number Analyzed	88 participants
		-2.2 (3.16)
Pressure	Number Analyzed	88 participants
		-2.7 (3.00)
Electric shocks	Number Analyzed	88 participants
		-2.9 (3.04)
Stabbing	Number Analyzed	88 participants
		-2.9 (3.10)
Brushing	Number Analyzed	86 participants
		-1.0 (2.99)
Increased by pressure	Number Analyzed	87 participants
		-2.4 (3.13)
Contact with cold	Number Analyzed	87 participants
		-1.2 (3.23)
Pins and needles	Number Analyzed	88 participants
		-3.2 (3.05)
Tingling	Number Analyzed	88 participants
		-2.9 (3.20)

67. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain), and are reported in categories below and 2 temporal questions (duration of pain, number of pain attacks). This assessment was done only in subjects from countries in which a validated version of the NPSI was available. Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline.
Time Frame	Baseline, Visit 9.1

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	85
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-3.1 (3.33)
Squeezing	-2.1 (3.20)
Pressure	-2.8 (3.10)
Electric shocks	-3.1 (3.36)
Stabbing	-2.9 (3.17)
Brushing	-1.0 (2.92)
Increased by pressure	-2.3 (3.00)
Contact with cold	-1.4 (2.78)
Pins and needles	-3.1 (3.25)
Tingling	-2.9 (3.33)

68. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.2

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	Number Analyzed	72 participants
		-3.2 (3.11)
Squeezing	Number Analyzed	72 participants
		-2.4 (3.15)
Pressure	Number Analyzed	72 participants
		-2.7 (3.37)
Electric shocks	Number Analyzed	72 participants
		-2.8 (3.41)
Stabbing	Number Analyzed	71 participants
		-3.0 (3.35)
Brushing	Number Analyzed	72 participants
		-1.0 (2.88)
Increased by pressure	Number Analyzed	72 participants
		-2.3 (3.00)
Contact with cold	Number Analyzed	72 participants
		-1.7 (2.56)
Pins and needles	Number Analyzed	72 participants
		-3.2 (3.18)
Tingling	Number Analyzed	72 participants
		-3.0 (3.19)

69. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.3

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	63
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-3.1 (3.00)
Squeezing	-1.9 (2.64)
Pressure	-2.6 (2.82)
Electric shocks	-3.0 (3.02)
Stabbing	-2.8 (3.38)
Brushing	-0.8 (2.88)
Increased by pressure	-2.5 (3.13)
Contact with cold	-1.5 (2.88)
Pins and needles	-2.9 (3.13)
Tingling	-3.3 (3.44)

70. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.4

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	62
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-2.8 (2.97)
Squeezing	-1.5 (2.74)
Pressure	-2.3 (3.01)
Electric shocks	-2.3 (3.61)
Stabbing	-2.8 (3.50)
Brushing	-0.9 (2.93)
Increased by pressure	-2.2 (2.97)
Contact with cold	-1.4 (2.76)
Pins and needles	-2.8 (3.3)
Tingling	-3.1 (3.26)

71. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.5

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	59
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-3.1 (3.09)
Squeezing	-2.0 (2.86)
Pressure	-2.4 (2.92)
Electric shocks	-2.8 (3.20)
Stabbing	-2.8 (3.36)
Brushing	-1.0 (2.65)
Increased by pressure	-2.3 (3.20)
Contact with cold	-1.6 (2.91)
Pins and needles	-3.0 (3.20)
Tingling	-3.1 (3.64)

72. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.6

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	55
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-3.0 (3.23)
Squeezing	-2.0 (3.02)
Pressure	-2.8 (2.84)
Electric shocks	-3.1 (3.37)
Stabbing	-2.8 (3.43)
Brushing	-0.8 (2.55)
Increased by pressure	-2.7 (3.04)
Contact with cold	-1.4 (2.65)
Pins and needles	-3.1 (3.25)
Tingling	-3.5 (3.31)

73. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.7

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	53
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-3.2 (3.34)
Squeezing	-2.1 (3.29)
Pressure	-2.2 (3.31)
Electric shocks	-2.9 (3.27)
Stabbing	-2.5 (3.52)
Brushing	-1.0 (2.87)
Increased by pressure	-2.5 (3.12)
Contact with cold	-1.2 (2.79)
Pins and needles	-3.2 (3.00)
Tingling	-3.3 (3.17)

74. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Visit 9.8

Outcome Measure Data

Analysis Population Description

Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	-2.3 (3.43)
Squeezing	-2.0 (2.89)
Pressure	-1.7 (2.00)
Electric shocks	-3.0 (2.65)
Stabbing	-2.5 (2.82)
Brushing	-0.4 (2.45)
Increased by pressure	-1.6 (2.06)
Contact with cold	-1.4 (1.92)
Pins and needles	-3.0 (2.94)
Tingling	-3.2 (3.15)

75. Secondary Outcome

Title	Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit
Description	Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Baseline, Termination Visit (last treatment visit)

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Burning	Number Analyzed	116 participants
		-2.6 (3.47)
Squeezing	Number Analyzed	115 participants
		-1.5 (3.20)
Pressure	Number Analyzed	115 participants
		-2.0 (3.21)
Electric shocks	Number Analyzed	116 participants
		-2.1 (3.54)
Stabbing	Number Analyzed	116 participants
		-2.3 (3.45)
Brushing	Number Analyzed	116 participants
		-1.0 (3.35)
Increased by pressure	Number Analyzed	116 participants
		-1.8 (3.16)
Contact with cold	Number Analyzed	116 participants
		-0.7 (3.15)
Pins and needles	Number Analyzed	116 participants
		-2.7 (3.36)
Tingling	Number Analyzed	116 participants
		-2.5 (3.83)

76. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline)
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 2 (Baseline)

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	141
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	37.6
Between 8 and 12 h	21.3
Between 4 and 7 h	19.1
Between 1 and 3 h	14.2
Less than 1 h	7.8

77. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 4

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	10.9
Between 8 and 12 h	13.6
Between 4 and 7 h	17.3
Between 1 and 3 h	20.9
Less than 1 h	37.3

78. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 6

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	103
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	12.6
Between 8 and 12 h	7.8
Between 4 and 7 h	11.7
Between 1 and 3 h	24.3
Less than 1 h	43.7

79. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.0

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	90
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	11.1
Between 8 and 12 h	8.9
Between 4 and 7 h	10.0
Between 1 and 3 h	22.2
Less than 1 h	47.8

80. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.1

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	86
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	9.3
Between 8 and 12 h	8.1
Between 4 and 7 h	15.1
Between 1 and 3 h	26.7
Less than 1 h	39.5
Not done	1.2

81. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.2

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	72
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	5.6
Between 8 and 12 h	9.7
Between 4 and 7 h	8.3
Between 1 and 3 h	22.2
Less than 1 h	54.2

82. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.3

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	64
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	3.1
Between 8 and 12 h	3.1
Between 4 and 7 h	15.6
Between 1 and 3 h	28.1
Less than 1 h	50.0

83. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.4

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	63
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	6.3
Between 8 and 12 h	11.1
Between 4 and 7 h	15.9
Between 1 and 3 h	22.2
Less than 1 h	44.4

84. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.5

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	60
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	8.3
Between 8 and 12 h	6.7
Between 4 and 7 h	15.0
Between 1 and 3 h	21.7
Less than 1 h	48.3

85. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.6

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	56
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	3.6
Between 8 and 12 h	10.7
Between 4 and 7 h	23.2
Between 1 and 3 h	17.9
Less than 1 h	44.6

86. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.7

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	54
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	7.4
Between 8 and 12 h	7.4
Between 4 and 7 h	14.8
Between 1 and 3 h	16.7
Less than 1 h	53.7

87. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.8

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	19
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	0
Between 8 and 12 h	10.5
Between 4 and 7 h	26.3
Between 1 and 3 h	26.3
Less than 1 h	36.8

88. Secondary Outcome

Title	Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit
Description	Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Termination Visit (last treatment visit)

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	118
Measure Type: Number; Unit of Measure: percentage of participants
Permanently	16.1
Between 8 and 12 h	13.6
Between 4 and 7 h	16.9
Between 1 and 3 h	18.6
Less than 1 h	34.7

89. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline)
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 2 (Baseline)

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	141
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	6.4
Between 1 and 5	33.3
Between 6 and 10	20.6
Between 11 and 20	20.6
More than 20	19.1
Not done	0

90. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 4

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	29.1
Between 1 and 5	39.1
Between 6 and 10	20.9
Between 11 and 20	5.5
More than 20	5.5
Not done	0

91. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 6

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	104
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	26.9
Between 1 and 5	42.3
Between 6 and 10	20.2
Between 11 and 20	7.7
More than 20	2.9
Not done	0

92. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.0

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	90
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	36.7
Between 1 and 5	35.6
Between 6 and 10	20.0
Between 11 and 20	5.6
More than 20	2.2
Not done	0

93. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.1

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	87
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	28.7
Between 1 and 5	34.5
Between 6 and 10	20.7
Between 11 and 20	4.6
More than 20	10.3
Not done	1.1

94. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.2

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	73
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	27.4
Between 1 and 5	49.3
Between 6 and 10	9.6
Between 11 and 20	9.6
More than 20	4.1
Not done	0

95. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.3

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	63
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	27.0
Between 1 and 5	44.4
Between 6 and 10	20.6
Between 11 and 20	3.2
More than 20	4.8
Not done	0

96. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.4

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	63
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	31.7
Between 1 and 5	33.3
Between 6 and 10	19.0
Between 11 and 20	11.1
More than 20	4.8
Not done	0

97. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.5

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	60
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	35.0
Between 1 and 5	35.0
Between 6 and 10	21.7
Between 11 and 20	3.3
More than 20	5.0
Not done	0

98. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.6

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	56
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	30.4
Between 1 and 5	44.6
Between 6 and 10	14.3
Between 11 and 20	5.4
More than 20	5.4
Not done	0

99. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.7

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	54
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	33.3
Between 1 and 5	37.0
Between 6 and 10	16.7
Between 11 and 20	5.6
More than 20	7.4
Not done	0

100. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Visit 9.8

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	19
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	26.3
Between 1 and 5	52.6
Between 6 and 10	15.8
Between 11 and 20	0
More than 20	5.3
Not done	0

101. Secondary Outcome

Title	Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit
Description	Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Time Frame	Termination Visit (last treatment visit)

Outcome Measure Data

Analysis Population Description

Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Arm/Group Title	Lacosamide
Arm/Group Description:	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed	118
Measure Type: Number; Unit of Measure: percentage of participants
No pain attack	28.8
Between 1 and 5	35.6
Between 6 and 10	15.3
Between 11 and 20	11.0
More than 20	9.3
Not done	0

102. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 4
Description	Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the physical component Summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 4

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	314 participants
		7.4 (19.99)
Role-Physical	Number Analyzed	314 participants
		13.1 (39.88)
Bodily Pain	Number Analyzed	315 participants
		20.8 (20.14)
General health	Number Analyzed	314 participants
		6.1 (16.18)
Vitality	Number Analyzed	315 participants
		8.5 (18.69)
Social Functioning	Number Analyzed	315 participants
		8.2 (23.79)
Role-Emotional	Number Analyzed	314 participants
		7.1 (45.48)
Mental Health	Number Analyzed	315 participants
		5.6 (18.20)
PCS	Number Analyzed	312 participants
		5.3 (7.62)
MCS	Number Analyzed	312 participants
		2.2 (10.68)

103. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 6
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 6

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	299 participants
		8.0 (20.55)
Role-Physical	Number Analyzed	298 participants
		12.1 (39.37)
Bodily Pain	Number Analyzed	299 participants
		22.4 (21.02)
General health	Number Analyzed	299 participants
		7.2 (17.48)
Vitality	Number Analyzed	299 participants
		8.4 (17.80)
Social Functioning	Number Analyzed	299 participants
		8.4 (24.47)
Role-Emotional	Number Analyzed	299 participants
		8.2 (45.11)
Mental Health	Number Analyzed	299 participants
		5.0 (17.79)
PCS	Number Analyzed	298 participants
		5.7 (8.13)
MCS	Number Analyzed	298 participants
		2.2 (10.66)

104. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.0

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	281 participants
		10.4 (21.86)
Role-Physical	Number Analyzed	280 participants
		17.5 (41.17)
Bodily Pain	Number Analyzed	281 participants
		25.3 (20.54)
General health	Number Analyzed	279 participants
		8.8 (16.56)
Vitality	Number Analyzed	281 participants
		10.5 (18.89)
Social Functioning	Number Analyzed	281 participants
		10.3 (25.41)
Role-Emotional	Number Analyzed	280 participants
		12.1 (49.96)
Mental Health	Number Analyzed	281 participants
		5.0 (18.01)
PCS	Number Analyzed	278 participants
		7.1 (7.90)
MCS	Number Analyzed	278 participants
		2.6 (11.39)

105. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.1

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	268 participants
		10.6 (20.97)
Role-Physical	Number Analyzed	267 participants
		18.4 (39.92)
Bodily Pain	Number Analyzed	268 participants
		24.6 (20.45)
General health	Number Analyzed	268 participants
		7.3 (17.95)
Vitality	Number Analyzed	268 participants
		9.6 (18.66)
Social Functioning	Number Analyzed	268 participants
		10.6 (23.58)
Role-Emotional	Number Analyzed	267 participants
		14.7 (47.66)
Mental Health	Number Analyzed	268 participants
		5.6 (17.83)
PCS	Number Analyzed	267 participants
		6.7 (8.18)
MCS	Number Analyzed	267 participants
		3.0 (10.83)

106. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.2

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	247 participants
		9.6 (21.54)
Role-Physical	Number Analyzed	247 participants
		19.2 (42.94)
Bodily Pain	Number Analyzed	248 participants
		23.8 (21.33)
General health	Number Analyzed	247 participants
		6.7 (18.83)
Vitality	Number Analyzed	248 participants
		9.7 (19.08)
Social Functioning	Number Analyzed	248 participants
		9.9 (24.79)
Role-Emotional	Number Analyzed	247 participants
		13.9 (48.28)
Mental Health	Number Analyzed	248 participants
		6.7 (18.18)
PCS	Number Analyzed	245 participants
		6.3 (8.31)
MCS	Number Analyzed	245 participants
		3.3 (11.39)

107. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.3

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	238 participants
		10.3 (21.03)
Role-Physical	Number Analyzed	237 participants
		20.2 (42.35)
Bodily Pain	Number Analyzed	238 participants
		26.3 (21.60)
General health	Number Analyzed	238 participants
		8.3 (17.29)
Vitality	Number Analyzed	238 participants
		9.9 (18.40)
Social Functioning	Number Analyzed	238 participants
		9.8 (24.74)
Role-Emotional	Number Analyzed	237 participants
		14.8 (50.82)
Mental Health	Number Analyzed	238 participants
		5.1 (18.52)
PCS	Number Analyzed	237 participants
		7.2 (8.03)
MCS	Number Analyzed	237 participants
		2.7 (11.76)

108. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.4

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	225 participants
		9.3 (21.35)
Role-Physical	Number Analyzed	224 participants
		17.3 (45.59)
Bodily Pain	Number Analyzed	225 participants
		24.1 (22.76)
General health	Number Analyzed	224 participants
		6.8 (18.43)
Vitality	Number Analyzed	225 participants
		8.7 (19.70)
Social Functioning	Number Analyzed	225 participants
		9.0 (28.04)
Role-Emotional	Number Analyzed	224 participants
		12.1 (49.30)
Mental Health	Number Analyzed	225 participants
		5.0 (18.17)
PCS	Number Analyzed	223 participants
		6.4 (8.63)
MCS	Number Analyzed	223 participants
		2.4 (11.74)

109. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.5

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: percentage of participants
Physical Functioning	Number Analyzed	213 participants
		8.6 (20.88)
Role-Physical	Number Analyzed	212 participants
		19.1 (45.41)
Bodily Pain	Number Analyzed	213 participants
		25.9 (22.49)
General health	Number Analyzed	211 participants
		7.9 (18.64)
Vitality	Number Analyzed	213 participants
		7.5 (18.55)
Social Functioning	Number Analyzed	213 participants
		8.2 (25.00)
Role-Emotional	Number Analyzed	212 participants
		9.9 (51.74)
Mental Health	Number Analyzed	213 participants
		3.7 (17.51)
PCS	Number Analyzed	210 participants
		7.0 (8.53)
MCS	Number Analyzed	210 participants
		1.4 (11.29)

110. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.6

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	203 participants
		8.6 (21.46)
Role-Physical	Number Analyzed	202 participants
		18.4 (46.02)
Bodily Pain	Number Analyzed	203 participants
		24.8 (22.45)
General health	Number Analyzed	203 participants
		7.0 (18.18)
Vitality	Number Analyzed	203 participants
		7.9 (18.39)
Social Functioning	Number Analyzed	203 participants
		8.8 (24.60)
Role-Emotional	Number Analyzed	202 participants
		12.7 (48.39)
Mental Health	Number Analyzed	203 participants
		4.9 (18.78)
PCS	Number Analyzed	202 participants
		6.5 (8.79)
MCS	Number Analyzed	202 participants
		2.3 (11.51)

111. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.7

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	184 participants
		9.4 (21.60)
Role-Physical	Number Analyzed	183 participants
		18.6 (46.18)
Bodily Pain	Number Analyzed	184 participants
		25.3 (22.4)
General Health	Number Analyzed	184 participants
		7.1 (19.13)
Vitality	Number Analyzed	184 participants
		7.4 (19.87)
Social Functioning	Number Analyzed	184 participants
		8.7 (26.12)
Role-Emotional	Number Analyzed	183 participants
		8.2 (54.47)
Mental Health	Number Analyzed	184 participants
		4.3 (17.44)
PCS	Number Analyzed	183 participants
		7.0 (8.62)
MCS	Number Analyzed	183 participants
		1.4 (11.93)

112. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Visit 9.8

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	49 participants
		6.9 (23.22)
Role-Physical	Number Analyzed	49 participants
		2.0 (41.09)
Bodily Pain	Number Analyzed	49 participants
		22.2 (20.13)
General health	Number Analyzed	49 participants
		0.2 (20.85)
Vitality	Number Analyzed	49 participants
		3.2 (22.95)
Social Functioning	Number Analyzed	49 participants
		4.3 (26.21)
Role-Emotional	Number Analyzed	49 participants
		-7.5 (52.38)
Mental Health	Number Analyzed	49 participants
		3.3 (19.48)
PCS	Number Analyzed	49 participants
		4.6 (8.33)
MCS	Number Analyzed	49 participants
		-0.9 (12.92)

113. Secondary Outcome

Title	Change in Quality of Life From Visit 2 (Baseline) to Termination Visit
Description	Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Time Frame	Baseline, Termination Visit (last treatment visit)

Outcome Measure Data

Analysis Population Description

371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Arm/Group Title		Lacosamide
Arm/Group Description:		Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Number of Participants Analyzed		371
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	323 participants
		5.0 (22.90)
Role-Physical	Number Analyzed	322 participants
		7.8 (41.56)
Bodily Pain	Number Analyzed	322 participants
		19.3 (23.63)
General Health	Number Analyzed	320 participants
		4.1 (18.72)
Vitality	Number Analyzed	319 participants
		4.5 (18.96)
Social Functioning	Number Analyzed	322 participants
		4.2 (25.94)
Role-Emotional	Number Analyzed	320 participants
		2.5 (51.05)
Mental Health	Number Analyzed	319 participants
		1.2 (18.72)
PCS	Number Analyzed	317 participants
		4.7 (8.44)
MCS	Number Analyzed	317 participants
		0.1 (11.41)

Adverse Events

Time Frame	From Baseline through Safety follow up visit (up to 140 weeks)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Lacosamide
Arm/Group Description	Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
All-Cause Mortality
	Lacosamide
	Affected / at Risk (%)
Total	7/371 (1.89%)
Serious Adverse Events
	Lacosamide
	Affected / at Risk (%)
Total	83/371 (22.37%)
Blood and lymphatic system disorders
Lymphadenopathy mediastinal * 1	1/371 (0.27%)
Cardiac disorders
Myocardial infarction * 1	3/371 (0.81%)
Angina pectoris * 1	2/371 (0.54%)
Myocardial ischaemia * 1	2/371 (0.54%)
Coronary artery disease * 1	2/371 (0.54%)
Arteriosclerosis coronary artery * 1	1/371 (0.27%)
Pericardial haemorrhage * 1	1/371 (0.27%)
Cardio-respiratory arrest * 1	1/371 (0.27%)
Cardiac failure * 1	1/371 (0.27%)
Bundle branch block right * 1	1/371 (0.27%)
Bundle branch block left * 1	1/371 (0.27%)
Atrial fibrillation * 1	1/371 (0.27%)
Aortic valve stenosis * 1	1/371 (0.27%)
Acute myocardial infarction * 1	1/371 (0.27%)
Cardiac failure acute * 1	1/371 (0.27%)
Ear and labyrinth disorders
Vestibular disorder * 1	2/371 (0.54%)
Endocrine disorders
Primary hyperaldosteronism * 1	1/371 (0.27%)
Eye disorders
Retinal detachment * 1	2/371 (0.54%)
Diabetic retinopathy * 1	2/371 (0.54%)
Cataract * 1	2/371 (0.54%)
Vitreous haemorrhage * 1	1/371 (0.27%)
Eye haemorrhage * 1	1/371 (0.27%)
Diplopia * 1	1/371 (0.27%)
Cataract diabetic * 1	1/371 (0.27%)
Corneal degeneration * 1	1/371 (0.27%)
Gastrointestinal disorders
Umbilical hernia * 1	2/371 (0.54%)
Pancreatitis acute * 1	1/371 (0.27%)
Pancreatitis * 1	1/371 (0.27%)
Gastritis erosive * 1	1/371 (0.27%)
Abdominal hernia * 1	1/371 (0.27%)
Gastric haemorrhage * 1	1/371 (0.27%)
General disorders
Chest pain * 1	2/371 (0.54%)
Non-cardiac chest pain * 1	1/371 (0.27%)
Multi-organ failure * 1	1/371 (0.27%)
Hepatobiliary disorders
Cholelithiasis * 1	1/371 (0.27%)
Biliary colic * 1	1/371 (0.27%)
Infections and infestations
Appendicitis * 1	2/371 (0.54%)
Urinary tract infection * 1	1/371 (0.27%)
Prostatic abscess * 1	1/371 (0.27%)
Postoperative wound infection * 1	1/371 (0.27%)
Hepatitis B * 1	1/371 (0.27%)
Gastroenteritis * 1	1/371 (0.27%)
Diabetic gangrene * 1	1/371 (0.27%)
Cellulitis * 1	1/371 (0.27%)
Pneumonia * 1	1/371 (0.27%)
Injury, poisoning and procedural complications
Lower limb fracture * 1	2/371 (0.54%)
Fall * 1	1/371 (0.27%)
Pubic rami fracture * 1	1/371 (0.27%)
Joint sprain * 1	1/371 (0.27%)
Head injury * 1	1/371 (0.27%)
Brain herniation * 1	1/371 (0.27%)
Ankle fracture * 1	1/371 (0.27%)
Investigations
Investigation * 1	1/371 (0.27%)
Echocardiogram abnormal * 1	1/371 (0.27%)
Metabolism and nutrition disorders
Diabetes mellitus * 1	2/371 (0.54%)
Hyperglycaemia * 1	2/371 (0.54%)
Diabetic foot * 1	2/371 (0.54%)
Diabetes mellitus non-insulin- dependent * 1	1/371 (0.27%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion * 1	2/371 (0.54%)
Osteoarthritis * 1	2/371 (0.54%)
Rotator cuff syndrome * 1	1/371 (0.27%)
Musculoskeletal pain * 1	1/371 (0.27%)
Toe deformity * 1	1/371 (0.27%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer * 1	2/371 (0.54%)
Bronchial carcinoma * 1	1/371 (0.27%)
Bladder transitional cell carcinoma * 1	1/371 (0.27%)
Gastric neoplasm * 1	1/371 (0.27%)
Colon adenoma * 1	1/371 (0.27%)
Leukaemia * 1	1/371 (0.27%)
Adenocarcinoma * 1	1/371 (0.27%)
Nervous system disorders
Cerebrovascular accident * 1	3/371 (0.81%)
Carotid artery stenosis * 1	2/371 (0.54%)
Neuritis * 1	1/371 (0.27%)
Dizziness * 1	1/371 (0.27%)
Transient ischaemic attack * 1	1/371 (0.27%)
Syncope vasovagal * 1	1/371 (0.27%)
Presyncope * 1	1/371 (0.27%)
Neuralgia * 1	1/371 (0.27%)
Lumbosacral plexus lesion * 1	1/371 (0.27%)
Headache * 1	1/371 (0.27%)
Cerebral haemorrhage * 1	1/371 (0.27%)
Brain oedema * 1	1/371 (0.27%)
Syncope * 1	1/371 (0.27%)
Psychiatric disorders
Suicide attempt * 1	1/371 (0.27%)
Mental disorder * 1	1/371 (0.27%)
Depression * 1	1/371 (0.27%)
Renal and urinary disorders
Renal failure * 1	1/371 (0.27%)
Reproductive system and breast disorders
Menorrhagia * 1	1/371 (0.27%)
Surgical and medical procedures
Stent placement * 1	1/371 (0.27%)
Gastric banding * 1	1/371 (0.27%)
Vascular disorders
Hypertension * 1	3/371 (0.81%)
Circulatory collapse * 1	1/371 (0.27%)
Phlebitis * 1	1/371 (0.27%)
Peripheral arterial occlusive disease * 1	1/371 (0.27%)
Hypotension * 1	1/371 (0.27%)
Hypertensive crisis * 1	1/371 (0.27%)
Femoral arterial stenosis * 1	1/371 (0.27%)
Arterial haemorrhage * 1	1/371 (0.27%)
Shock haemorrhagic * 1	1/371 (0.27%)
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lacosamide
	Affected / at Risk (%)
Total	229/371 (61.73%)
Ear and labyrinth disorders
Vertigo * 1	45/371 (12.13%)
Gastrointestinal disorders
Nausea * 1	49/371 (13.21%)
Vomiting * 1	21/371 (5.66%)
General disorders
Fatigue * 1	31/371 (8.36%)
Oedema peripheral * 1	20/371 (5.39%)
Infections and infestations
Nasopharyngitis * 1	43/371 (11.59%)
Influenza * 1	21/371 (5.66%)
Musculoskeletal and connective tissue disorders
Back pain * 1	26/371 (7.01%)
Nervous system disorders
Dizziness * 1	75/371 (20.22%)
Headache * 1	44/371 (11.86%)
Somnolence * 1	34/371 (9.16%)
Tremor * 1	24/371 (6.47%)
Vascular disorders
Hypertension * 1	26/371 (7.01%)
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: 001 844 599 2273
• EMail: UCBCares@ucb.com

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00220337
• Other Study ID Numbers: SP0830; 2004-000960-28 ( EudraCT Number )
• First Submitted: September 1, 2005
• First Posted: September 22, 2005
• Results First Submitted: February 13, 2018
• Results First Posted: July 24, 2023
• Last Update Posted: July 24, 2023