A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

• ClinicalTrials.gov Identifier: NCT00350103
• Recruitment Status: Completed
• First Posted: July 10, 2006
• Results First Posted: March 22, 2024
• Last Update Posted: March 22, 2024
• Sponsor: UCB Pharma
• Collaborator: SCHWARZ BIOSCIENCES GmbH - Part of UCB Group
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Painful Diabetic Neuropathy
• Interventions: Drug: SPM 929; Drug: Placebo
• Enrollment: 551

Participant Flow

Recruitment Details	The study started to enroll patients in June 2006 and concluded in June 2007.
Pre-assignment Details	Participant Flow refers to the Randomized Set. The 16-week Treatment Phase consisted of 4-week Titration Phase and 12-week Maintenance Phase.

Arm/Group Title	Placebo	Lacosamide Fast Titration (FT)	Lacosamide Standard Titration (ST)
Arm/Group Description	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Period Title: Overall Study
Started	179	190	182
Entered Titration Phase [1]	179	189	181
Completed Titration Phase	162	164	165
Entered Maintenance Phase	162	163	164
Completed Maintenance Phase	150	149	148
Completed	149	148	146
Not Completed	30	42	36
Reason Not Completed
Adverse Event	12	29	17
Lack of Efficacy	5	1	3
Withdrawal by Subject	6	6	8
Protocol Violation	0	0	1
Unsatisfactory Compliance	2	2	1
Investigator´s decision	1	1	0
Exclusion criteria met	0	0	1
Patient relocated	0	0	1
Need for prohibited medication	1	0	0
Personal reasons	0	0	1
Patient stopped feeling pain	1	0	0
PR greater than 250ms	0	0	1
Wrong calculation of QT interval	0	0	1
Sponsor mistake	1	0	0
Randomization mistake	0	1	1
Sponsor´s decision	0	1	0
Lost, Reason unknown	1	1	0
[1] Received at least 1 dose of study medication (Safety Set)

Baseline Characteristics

Arm/Group Title		Placebo	Lacosamide FT	Lacosamide ST	Total Title
Arm/Group Description		Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	[Not Specified]
Overall Number of Baseline Participants		179	190	182	551
Baseline Analysis Population Description		Baseline Characteristics refer to the Randomized Set which included all enrolled participants who were randomized to a specific treatment arm.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	179 participants	190 participants	182 participants	551 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	142 79.3%	147 77.4%	134 73.6%	423 76.8%
	>=65 years	37 20.7%	43 22.6%	48 26.4%	128 23.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	179 participants	190 participants	182 participants	551 participants
		56.6 (9.45)	58.0 (9.46)	57.4 (10.14)	57.3 (9.68)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	179 participants	190 participants	182 participants	551 participants
	Female	86 48.0%	98 51.6%	88 48.4%	272 49.4%
	Male	93 52.0%	92 48.4%	94 51.6%	279 50.6%

Outcome Measures

1. Primary Outcome

Title	Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.
Time Frame	Last 4 weeks of Maintenance Phase, compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.9 (2.20)	-2.2 (2.05)	-2.4 (2.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lacosamide ST
	Comments	Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.0410
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.88 to -0.02
	Estimation Comments	Estimated value is the difference of Least Square Means.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lacosamide FT
	Comments	Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.2902
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -0.65 to 0.20
	Estimation Comments	Estimated value is the difference of Least Square Means.

2. Secondary Outcome

Title	Time to Sustainable Pain Relief
Description	Time to sustainable pain relief was defined as the time from Baseline to the first day on which there was a ≥1-point improvement over Baseline in the Likert pain score for those subjects for whom there was also ≥30% reduction in average daily pain score over the last 28 days of the Maintenance Phase as compared to Baseline.
Time Frame	From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Median (95% Confidence Interval); Unit of Measure: days
	31.0 [1]; (11.0 to NA)	11.0; (7.0 to 35.0)	10.0 [1]; (6.0 to NA)

[1]

Upper confidence limits are not provided for the 95% CI of the median time to sustainable pain relief when there is no observed sustainable pain relief time for which the upper bound of the confidence interval for the Kaplan-Meier estimate is less than 0.5.

3. Secondary Outcome

Title	Percentage of Subjects With >= 30% or >= 2-point Reduction of with-in Subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of the Maintenance Phase
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening.
Time Frame	Baseline week, last 4 weeks of the Maintenance Phase

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Measure Type: Number; Unit of Measure: percentage of participants
	50.3	56.4	55.4

4. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Time Frame	Baseline week, Visit 3

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.5 (1.13)	-0.7 (1.07)	-0.7 (1.06)

5. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Time Frame	Baseline week, Visit 4

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	171	182	170
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.9 (1.47)	-1.4 (1.63)	-1.3 (1.50)

6. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Time Frame	Baseline week, Visit 5

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	168	172	169
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.3 (1.73)	-1.7 (1.87)	-1.8 (1.69)

7. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Time Frame	Baseline week, Visit 6

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	162	163	164
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.9 (2.01)	-2.1 (2.08)	-2.2 (1.94)

8. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Time Frame	Baseline week, Visit 7

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	157	153	152
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.2 (2.09)	-2.3 (2.03)	-2.5 (1.98)

9. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.
Time Frame	Baseline week, Visit 8

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	152	151	150
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.2 (2.17)	-2.5 (2.07)	-2.6 (2.07)

10. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.
Time Frame	Titration Phase (4 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.0 (1.40)	-1.3 (1.47)	-1.4 (1.35)

11. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to the Maintenance Phase
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.
Time Frame	Maintenance Phase (12 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	162	163	164
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.1 (2.04)	-2.3 (1.98)	-2.3 (1.92)

12. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to the Treatment Phase
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.
Time Frame	Treatment Phase (16 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.6 (1.83)	-1.9 (1.76)	-2.0 (1.72)

13. Secondary Outcome

Title	Within-subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of Maintenance Phase
Description	An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.
Time Frame	Last 4 weeks of Maintenance Phase, compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.9 (2.20)	-2.2 (2.05)	-2.4 (2.08)

14. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.
Time Frame	Baseline Week, Visit 3

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	186	176
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.5 (1.27)	-0.7 (1.26)	-0.6 (1.35)

15. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.
Time Frame	Baseline Week, Visit 4

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	171	180	169
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.9 (1.72)	-1.3 (1.69)	-1.3 (1.83)

16. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.
Time Frame	Baseline Week, Visit 5

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	168	170	168
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.4 (1.87)	-1.7 (2.04)	-1.8 (2.01)

17. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.
Time Frame	Baseline Week, Visit 6

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	162	161	163
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.9 (2.15)	-2.0 (2.28)	-2.2 (2.26)

18. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.
Time Frame	Baseline Week, Visit 7

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	157	151	151
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.2 (2.19)	-2.3 (2.22)	-2.5 (2.37)

19. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.
Time Frame	Baseline Week, Visit 8

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	152	149	149
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.1 (2.28)	-2.5 (2.26)	-2.5 (2.38)

20. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.
Time Frame	Titration Phase (4 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	186	176
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.0 (1.54)	-1.3 (1.62)	-1.3 (1.67)

21. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.
Time Frame	Maintenance Phase (12 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	162	161	163
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.0 (2.15)	-2.2 (2.22)	-2.4 (2.24)

22. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's Sleep
Description	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. A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.
Time Frame	Treatment Phase (16 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	186	176
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.6 (1.94)	-1.8 (1.94)	-2.0 (2.04)

23. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Last 4 Weeks of Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep
Description	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 lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.
Time Frame	Last 4 weeks of Maintenance Phase, compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	186	176
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.9 (2.30)	-2.1 (2.24)	-2.3 (2.37)

24. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.
Time Frame	Baseline Week, Visit 3

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	187	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.6 (1.30)	-0.7 (1.26)	-0.7 (1.40)

25. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.
Time Frame	Baseline Week, Visit 4

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	171	181	170
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.0 (1.57)	-1.3 (1.70)	-1.3 (1.84)

26. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.
Time Frame	Baseline Week, Visit 5

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	168	171	169
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.4 (1.83)	-1.6 (2.01)	-1.8 (2.11)

27. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.
Time Frame	Baseline Week, Visit 6

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	162	162	164
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.9 (2.15)	-2.0 (2.12)	-2.1 (2.28)

28. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.
Time Frame	Baseline Week, Visit 7

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	157	152	152
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.2 (2.24)	-2.3 (2.11)	-2.3 (2.37)

29. Secondary Outcome

Title	Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.
Time Frame	Baseline Week, Visit 8

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	152	150	150
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.1 (2.29)	-2.4 (2.15)	-2.4 (2.42)

30. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.
Time Frame	Titration Phase (4 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	187	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.0 (1.50)	-1.2 (1.60)	-1.3 (1.72)

31. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.
Time Frame	Maintenance Phase (12 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	162	162	164
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.0 (2.17)	-2.2 (2.05)	-2.2 (2.27)

32. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.
Time Frame	Treatment Phase (16 weeks), compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	187	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.6 (1.94)	-1.8 (1.85)	-1.9 (2.06)

33. Secondary Outcome

Title	Within-subject Change From the Baseline Week to the Last 4 Weeks of the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity
Description	An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.
Time Frame	Last 4 weeks of Maintenance Phase, compared to the Baseline Week

Outcome Measure Data

Analysis Population Description

Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	187	177
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.9 (2.30)	-2.1 (2.16)	-2.2 (2.38)

34. Secondary Outcome

Title	Percentage of Days of Rescue Medication Use During the Treatment Phase
Description	Percentage of days of rescue medication use was the number of days in the visit/trial phase with rescue medication use divided by the total number of days in the visit/trial phase times 100.
Time Frame	During the Treatment Phase (up to 16 weeks)

Outcome Measure Data

Analysis Population Description

Only subjects with available data for rescue medication use are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	177	188	177
Mean (Standard Deviation); Unit of Measure: percentage of days
	6.6 (20.27)	7.0 (20.28)	9.1 (23.67)

35. Secondary Outcome

Title	Within-subject Change From Baseline to Visit 8 in Subject's Quality of Life
Description	Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey. 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 contribute to the physical component Summary (PCS) score. Items 5-8 contribute to the mental component summary (MCS) score. 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 change value indicates improvement from baseline. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) groups.
Time Frame	Baseline, Visit 8

Outcome Measure Data

Analysis Population Description

A total of 177 subjects treated with Placebo and 365 subjects treated with lacosamide were initially included in the Full Analysis Set. Only subjects with available data for change from Baseline to Visit 8 in the sub-scores of subject's quality of life are included in the analysis. Number of subjects analyzed is given separately per sub-score.

Arm/Group Title		Placebo	Lacosamide Pooled FT and ST
Arm/Group Description:		Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects received LCM as Fast Titration (FT) or Standard Titration (ST).
Overall Number of Participants Analyzed		177	365
Mean (Standard Deviation); Unit of Measure: units on a scale
Physical Functioning	Number Analyzed	169 participants	345 participants
		3.8 (16.30)	4.4 (18.85)
Role-Physical	Number Analyzed	168 participants	345 participants
		15.3 (37.80)	10.3 (39.33)
Bodily Pain	Number Analyzed	169 participants	345 participants
		13.4 (20.51)	16.9 (19.99)
General Health	Number Analyzed	169 participants	343 participants
		5.0 (15.09)	4.8 (15.39)
Vitality	Number Analyzed	169 participants	344 participants
		4.4 (16.12)	7.5 (17.94)
Social Functioning	Number Analyzed	169 participants	345 participants
		8.4 (23.05)	5.1 (22.37)
Role-Emotional	Number Analyzed	168 participants	345 participants
		6.5 (44.42)	4.7 (47.28)
Mental Health	Number Analyzed	169 participants	344 participants
		3.5 (16.97)	4.8 (18.60)
PCS	Number Analyzed	168 participants	342 participants
		3.9 (6.61)	4.0 (6.99)
MCS	Number Analyzed	168 participants	342 participants
		1.9 (10.06)	1.8 (10.91)

36. Secondary Outcome

Title	Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 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. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) reporting groups.
Time Frame	Visit 8

Outcome Measure Data

Analysis Population Description

Only subjects with available data for Patient's Global Impression of Change in Pain are included in the analysis.

Arm/Group Title	Placebo	Lacosamide Pooled FT and ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects received LCM as Fast Titration (FT) or Standard Titration (ST).
Overall Number of Participants Analyzed	171	343
Measure Type: Number; Unit of Measure: percentage of participants
Much worse	1.2	0.6
Moderately worse	1.2	1.7
Mildly worse	3.5	2.6
No change	23.4	17.8
Mildly better	31.6	23.3
Moderately better	26.9	32.4
Much better	12.3	21.6

37. Secondary Outcome

Title	Percentage of Patients With Categorized Satisfaction With Medications at Visit 8
Description	Categories of satisfaction are as following: very satisfied, satisfied, neither satisfied/dissatisfied, dissatisfied, very dissatisfied, not applicable, not done (no data available).
Time Frame	Visit 8

Outcome Measure Data

Analysis Population Description

Only subjects with available data for satisfaction with medications are included in the analysis.

Arm/Group Title	Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed	171	178	168
Measure Type: Number; Unit of Measure: percentage of participants
Very Satisfied	11.7	14.0	15.5
Satisfied	43.9	45.5	50.0
Neither Satisfied/Dissatisfied	25.7	24.2	23.8
Dissatisfied	11.7	11.8	8.3
Very Dissatisfied	4.1	2.8	0.6
Not Applicable	0	0.6	0
Not Done	2.9	1.1	1.8

38. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores at Visit 8
Description	The MOS Sleep scale is used to assess the subject's quality of sleep. The scale consists of 12 individual items categorized into two sleep problems indices (SPI I/II) and 5 subscales: sleep disturbance, sleep somnolence, snoring, short of breath (SoB) or headache, sleep adequacy. Scores range from 0 to 100. Sleep adequacy scale: High values indicate a high quality of sleep. A positive change indicates improvement in quality of sleep. All other Sleep Scales: Low values indicate a high quality of sleep. A negative change indicates improvement in quality of sleep.
Time Frame	Baseline, Visit 8

Outcome Measure Data

Analysis Population Description

177 subjects treated with Placebo, 188 subjects treated with Lacosamide FT and 177 subjects treated with Lacosamide ST were initially included in the FAS. Only subjects with available data for change from Baseline to Visit 8 in MOS sleep scale scores are included in the analysis. Number of subjects analyzed is given separately per sub-score.

Arm/Group Title		Placebo	Lacosamide FT	Lacosamide ST
Arm/Group Description:		Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
Overall Number of Participants Analyzed		177	188	177
Mean (Standard Deviation); Unit of Measure: units on a scale
Sleep Disturbance	Number Analyzed	105 participants	116 participants	106 participants
		-13.4 (19.30)	-15.2 (22.65)	-17.1 (23.97)
Sleep Somnolence	Number Analyzed	105 participants	116 participants	106 participants
		-7.0 (16.25)	-2.1 (19.69)	-4.6 (20.41)
Snoring	Number Analyzed	105 participants	115 participants	104 participants
		-2.7 (27.33)	0.0 (25.13)	-6.7 (27.25)
SoB/ Headache	Number Analyzed	105 participants	116 participants	106 participants
		-6.7 (23.32)	-1.0 (26.75)	-7.5 (24.76)
Sleep Adequacy	Number Analyzed	105 participants	116 participants	106 participants
		7.2 (26.11)	10.3 (26.37)	15.1 (30.28)
SPI I	Number Analyzed	105 participants	116 participants	106 participants
		-10.3 (15.15)	-8.3 (17.39)	-12.2 (19.58)
SPI II	Number Analyzed	105 participants	116 participants	106 participants
		-10.6 (14.18)	-9.9 (16.66)	-13.1 (19.17)

Adverse Events

Time Frame	Adverse events were collected from baseline until the end of the trial (up to Week 18)
Adverse Event Reporting Description	Adverse Events refer to the Safety Set, consisting of all randomized subjects who took at least one dose of study medication. It was pre-specified in the Statistical Analysis Plan that AEs will be summarized and disclosed for placebo and LCM 400 mg/day (pooled) for all participants, who took at least one dose of medication (Safety Set). AEs were planned to be collected and summarized irrespective of dosing strategy.
Arm/Group Title	Placebo	Lacosamide Pooled FT and ST
Arm/Group Description	Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.	Subjects received LCM as Fast Titration (FT) or Standard Titration (ST).
All-Cause Mortality
	Placebo	Lacosamide Pooled FT and ST
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/179 (0.00%)	0/370 (0.00%)
Serious Adverse Events
	Placebo	Lacosamide Pooled FT and ST
	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/179 (7.82%)	28/370 (7.57%)
Cardiac disorders
Atrial flutter 1	0/179 (0.00%)	1/370 (0.27%)
Atrial fibrillation 1	0/179 (0.00%)	1/370 (0.27%)
Bundle branch block left 1	0/179 (0.00%)	1/370 (0.27%)
Acute myocardial infarction 1	1/179 (0.56%)	0/370 (0.00%)
Eye disorders
Diabetic retinopathy 1	1/179 (0.56%)	0/370 (0.00%)
Gastrointestinal disorders
Jejunitis 1	0/179 (0.00%)	1/370 (0.27%)
General disorders
Asthenia 1	1/179 (0.56%)	1/370 (0.27%)
Hepatobiliary disorders
Biliary colic 1	0/179 (0.00%)	1/370 (0.27%)
Infections and infestations
Respiratory tract infection viral 1	0/179 (0.00%)	1/370 (0.27%)
Gangrene 1	0/179 (0.00%)	1/370 (0.27%)
Gastroenteritis 1	0/179 (0.00%)	1/370 (0.27%)
Appendicitis 1	1/179 (0.56%)	0/370 (0.00%)
Orchitis 1	1/179 (0.56%)	0/370 (0.00%)
Injury, poisoning and procedural complications
Upper limb fracture 1	0/179 (0.00%)	1/370 (0.27%)
Investigations
Electrocardiogram PR prolongation 1	1/179 (0.56%)	0/370 (0.00%)
Metabolism and nutrition disorders
Diabetic foot 1	0/179 (0.00%)	1/370 (0.27%)
Diabetic ketoacidosis 1	0/179 (0.00%)	1/370 (0.27%)
Diabetes mellitus 1	1/179 (0.56%)	0/370 (0.00%)
Hyperglycaemia 1	1/179 (0.56%)	0/370 (0.00%)
Musculoskeletal and connective tissue disorders
Osteoarthritis 1	0/179 (0.00%)	1/370 (0.27%)
Toe deformity 1	0/179 (0.00%)	1/370 (0.27%)
Spinal column stenosis 1	1/179 (0.56%)	0/370 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrinoma 1	0/179 (0.00%)	1/370 (0.27%)
Nervous system disorders
Cerebrovascular accident 1	0/179 (0.00%)	2/370 (0.54%)
Vertebrobasilar insufficiency 2	0/179 (0.00%)	1/370 (0.27%)
Cerebellar syndrome 2	0/179 (0.00%)	1/370 (0.27%)
Ischaemic stroke 2	0/179 (0.00%)	1/370 (0.27%)
Presyncope 2	0/179 (0.00%)	1/370 (0.27%)
Sciatica 2	0/179 (0.00%)	1/370 (0.27%)
Neuropathy 2	1/179 (0.56%)	0/370 (0.00%)
Renal and urinary disorders
Renal colic 2	1/179 (0.56%)	2/370 (0.54%)
Reproductive system and breast disorders
Metrorrhagia 2	0/179 (0.00%)	1/370 (0.27%)
Vaginal haemorrhage 2	0/179 (0.00%)	1/370 (0.27%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease 2	1/179 (0.56%)	0/370 (0.00%)
Surgical and medical procedures
Intestinal operation 2	0/179 (0.00%)	1/370 (0.27%)
Vascular disorders
Arterial occlusive disease 2	0/179 (0.00%)	2/370 (0.54%)
Peripheral ischaemia 2	0/179 (0.00%)	1/370 (0.27%)
Thrombosis 2	0/179 (0.00%)	1/370 (0.27%)
Hypertension 2	1/179 (0.56%)	0/370 (0.00%)
Peripheral arterial occlusive disease 2	1/179 (0.56%)	0/370 (0.00%)
1 Term from vocabulary, MedDRA 9.1; 2 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Lacosamide Pooled FT and ST
	Affected / at Risk (%)	Affected / at Risk (%)
Total	21/179 (11.73%)	82/370 (22.16%)
Ear and labyrinth disorders
Vertigo 1	2/179 (1.12%)	21/370 (5.68%)
Gastrointestinal disorders
Nausea 1	4/179 (2.23%)	28/370 (7.57%)
Infections and infestations
Nasopharyngitis 1	11/179 (6.15%)	20/370 (5.41%)
Nervous system disorders
Dizziness 1	3/179 (1.68%)	29/370 (7.84%)
Headache 1	6/179 (3.35%)	23/370 (6.22%)
1 Term from vocabulary, MedDRA

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

Publications of Results:

Bainbridge J, De Backer M, Eckhardt K, Tennigkeit F, Bongardt S, Sen D, Werhahn KJ, Shaibani A, Faught E. Safety and tolerability of lacosamide monotherapy in the elderly: A subgroup analysis from lacosamide trials in diabetic neuropathic pain. Epilepsia Open. 2017 Sep 11;2(4):415-423. doi: 10.1002/epi4.12079. eCollection 2017 Dec.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00350103
• Other Study ID Numbers: SP0874; 2005-005788-27 ( EudraCT Number )
• First Submitted: July 6, 2006
• First Posted: July 10, 2006
• Results First Submitted: February 13, 2018
• Results First Posted: March 22, 2024
• Last Update Posted: March 22, 2024