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Trial record 1 of 1 for:    EP0012
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Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures (VALUE)

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ClinicalTrials.gov Identifier: NCT02408549
Recruitment Status : Completed
First Posted : April 3, 2015
Results First Posted : December 14, 2023
Last Update Posted : December 14, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: Lacosamide Tablet
Drug: Lacosamide Oral Solution
Enrollment 239
Recruitment Details The study started to enroll participants in August 2015 and concluded in March 2023. Study participants from SP0982 [NCT02408523], who met EP0012 eligibility criteria were enrolled.
Pre-assignment Details The Participant Flow refers to the Safety Set. The Safety Set included all study participants who received at least 1 dose of Investigational medicinal product (IMP) during this study.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Period Title: Overall Study
Started 239
Completed 157
Not Completed 82
Reason Not Completed
Adverse Event             15
Death             4
Lack of Efficacy             17
Protocol Violation             4
Lost to Follow-up             6
Consent withdrawn             30
Neurology research program closing at site             1
Site closure             1
Pregnancy             1
Withdrawal of consent due to business trip             1
Subject moved to another place, far from site             1
Study terminated at site             1
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Baseline Participants 239
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set which consisted of all study participants who received at least 1 dose of IMP during this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants
27.9  (12.6)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
≥4-<12 years
16
   6.7%
12-<18 years
28
  11.7%
18-<65 years
194
  81.2%
≥65 years
1
   0.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Female
134
  56.1%
Male
105
  43.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
American Indian/Alaskan Native
1
   0.4%
Asian
48
  20.1%
Black
4
   1.7%
White
178
  74.5%
Other/Mixed
8
   3.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants
Hispanic or Latino
28
  11.7%
Not Hispanic or Latino
211
  88.3%
1.Primary Outcome
Title Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period
Hide Description AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. Adverse Events were reported spontaneously by the participant and/or caregiver or observed by the investigator.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Count of Participants
Unit of Measure: Participants
222
  92.9%
2.Primary Outcome
Title Number of Study Participants Withdrawn Due to TEAEs
Hide Description AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. Adverse Events were reported spontaneously by the participant and/or caregiver or observed by the investigator.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Count of Participants
Unit of Measure: Participants
19
   7.9%
3.Primary Outcome
Title Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
Hide Description The number of study participants with appearance of new absence and/or myoclonic seizure types experienced during the Treatment Period but who did not experience in Combined Baseline Period or in seizure classification history, before taking LCM were reported. To determine appearance of new seizure type, the Combined Baseline Period was used. Thus, the participants who directly enrolled into EP0012, the Baseline absence, and/or myoclonic seizure data from SP0982's 4-week Prospective Baseline Period were combined with any reported Baseline absence, and myoclonic seizure information in the daily seizure diary from EP0012 (reported before first dose in EP0012) to recalculate the study participant's Baseline variables such as days with absence, and/or myoclonic seizures per 28 days.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Count of Participants
Unit of Measure: Participants
Absence seizures
3
   1.3%
Myoclonic seizures
5
   2.1%
4.Primary Outcome
Title Number of Study Participants With an Increase of up to 25% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of up to 25% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
5
   5.4%
5.Primary Outcome
Title Number of Study Participants With an Increase of Greater Than (>)25% to 50% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of >25% to 50% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.1%
6.Primary Outcome
Title Number of Study Participants With an Increase of >50% to 75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of >50% to 75% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Primary Outcome
Title Number of Study Participants With an Increase of >75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of >75% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
8.Primary Outcome
Title Number of Study Participants With an Increase of up to 25% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of up to 25% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
4
   4.2%
9.Primary Outcome
Title Number of Study Participants With an Increase of >25% to 50% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of >25% to 50% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.0%
10.Primary Outcome
Title Number of Study Participants With an Increase of >50% to 75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of >50% to 75% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.0%
11.Primary Outcome
Title Number of Study Participants With an Increase of >75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Hide Description The number of participants experiencing an increase of >75% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.1%
12.Primary Outcome
Title Percentage of Study Participants With at Least 50% Worsening in Days With Absence Seizures
Hide Description Seizure worsening was defined as a participant experiencing >=50% increase in the number of days with absence seizures per 28 days from Prospective Baseline. Percentages for seizure worsening were based on those participants who have reported a history of or an occurrence of absence seizures in Prospective Baseline or the Treatment Period.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: percentage of participants
0
13.Primary Outcome
Title Percentage of Study Participants With at Least 50% Worsening in Days With Myoclonic Seizures
Hide Description Seizure worsening was defined as a participant experiencing >=50% increase in the number of days with myoclonic seizures per 28 days from Prospective Baseline. Percentages for seizure worsening were based on those participants who have reported a history of or an occurrence of myoclonic seizures in Prospective Baseline or the Treatment Period.
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures).
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: percentage of participants
3.2
14.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Hide Description TEMA values are defined in the Statistical Analysis Plan (SAP) as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Hematology parameter, Hemoglobin were those that were observed post-Baseline (BL) during the Treatment Period but not present at Baseline. For the age range, '2 years (y) to <17 years', the abnormality criteria were '<=95' grams/deciliter (g/dL) (Low) and '>160' g/dL (High). For age range, '>=17 years', the abnormality Criteria were '<=85% of lower limit of normal (LLN)' value (Low) and '>=115% of upper limit of normal (ULN)' value (High) of Hemoglobin in blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Hemoglobin) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
Low: Week (Wk) 78 (2-<17 y) Number Analyzed 7 participants
14.3
Low: Wk 0 (>=17 y) Number Analyzed 27 participants
3.7
Low: Wk 2 (>=17 y) Number Analyzed 195 participants
0.5
Low: Wk 118 (>=17 y) Number Analyzed 123 participants
0.8
Low: Wk 166 (>=17 y) Number Analyzed 81 participants
1.2
Low: Wk 214 (>=17 y) Number Analyzed 40 participants
2.5
Low: Termination Visit (TV) (>=17 y) Number Analyzed 123 participants
1.6
15.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Hematocrit were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '2 years to <17 years', the abnormality criteria were '<=29%' (Low) and '>47%' (High) hematocrit values. For age range, '>=17 years', the abnormality criteria were '<=85% of LLN' (Low) and '>=115% of ULN' (High) of Hematocrit values in blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Hematocrit) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
High: Wk 22 (2-<17 y) Number Analyzed 29 participants
6.9
High: Wk 46 (2-<17 y) Number Analyzed 27 participants
3.7
Low: Wk 46 (>=17 y) Number Analyzed 170 participants
1.2
Low: Wk 118 (>=17 y) Number Analyzed 123 participants
1.6
Low: Wk 166 (>=17 y) Number Analyzed 81 participants
1.2
Low: TV (>=17 y) Number Analyzed 123 participants
0.8
16.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Platelets)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Platelet count were those that were observed post-BL during the Treatment Period but not present at BL. For the age range of '>1 month', the abnormality criteria were '<=100' 10^9/L and '>=600' 10^9/L of Platelets count value.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (platelets) with markedly abnormal criteria specified at any visit.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
17.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Erythrocytes)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Erythrocytes parameter were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '>=2years', the abnormality criteria were '<3.5' 10^12/L of Erythrocytes value in blood. Early Termination Visit (TV) was last visit in the study (up to approximately 5 years).
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Early TV) wherein at least 1 TEMA value of Hematology parameter (Erythrocytes) observed during the study was reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: percentage of participants
1.7
18.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Leukocytes)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Leukocytes were those that were observed post-BL during the Treatment Period but not present at BL. For all age ranges, the abnormality criteria were '<=3.0' 10^9/L (Low) and '>= 16.0' 10^9/L (High) of Leukocytes values in blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Week 62-Low) wherein at least 1 TEMA value of Hematology parameter (Leukocytes) observed during the study was reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: percentage of participants
0.5
19.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Basophils Absolute)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Basophils Absolute were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '>1 month', the abnormality criteria were '>=0.4' 10^9/L of Basophils in blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Week 2) wherein at least 1 TEMA value of Hematology parameter (Basophils Absolute) observed during the study was reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: percentage of participants
0.4
20.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Eosinophils Absolute were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '>1 month', the abnormality criteria were '>=1.0' 10^9/L of Eosinophils in the blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Eosinophils Absolute) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: percentage of participants
>=1.0: Wk 2 (>1 month) Number Analyzed 228 participants
0.9
>=1.0: Wk 22 (>1 month) Number Analyzed 215 participants
0.5
>=1.0: TV (>1 month) Number Analyzed 134 participants
1.5
21.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Lymphocytes Absolute)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Lymphocytes Absolute were those that were observed post-Baseline (BL) during the Treatment Period but not present at Baseline. For the age range, '2 years - <6 years', the abnormality criteria were '<0.7' 10^9/L (Low) and '>6.9' 10^9/L (High). For age range, '>=6 years', the abnormality criteria were '<0.6' 10^9/L (Low) and '>5.0' 10^9/L (High) for Lymphocytes Absolute in the blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Lymphocytes Absolute) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: percentage of participants
High: Wk 2 (>=6 y) Number Analyzed 226 participants
0.4
High: Wk 78 (>=6 y) Number Analyzed 63 participants
3.2
High: Wk 118 (>=6 y) Number Analyzed 141 participants
0.7
22.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Monocytes Absolute )
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Monocytes Absolute were those that are observed post-BL during the Treatment Period but not present at BL. For the age range, '>1 month', the abnormality criteria was '>=2.0' 10^9/L of Monocytes in blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (Monocytes Absolute) with markedly abnormal criteria specified at any visit.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
23.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Neutrophils Absolute were those that were observed post-BL during the Treatment Period but not present at BL. For the age range, '>1 month', the abnormality criteria was '<1.5' 10^9/L of Neutrophils in blood.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Neutrophils Absolute) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: percentage of participants
<1.5: Wk 2 (>1 m) Number Analyzed 228 participants
0.9
<1.5: Wk 22 (>1 m) Number Analyzed 215 participants
0.5
<1.5: Wk 46 (>1 m) Number Analyzed 196 participants
0.5
<1.5: Wk 62 (>1 m) Number Analyzed 191 participants
0.5
<1.5: Wk 94 (>1 m) Number Analyzed 162 participants
0.6
<1.5: Wk 214 (>1 m) Number Analyzed 42 participants
2.4
24.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Calcium)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Calcium were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year -<17 years', the abnormality criteria were '<=1.85' millimoles per litre (mmol/L) and '>=2.95' mmol/L. For age range, '>=17 years', the abnormality criteria was '<=1.9 mmol/L' and '>=2.75 mmol/L' of serum Calcium.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (Calcium) with markedly abnormal criteria specified at any visit.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
25.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Sodium)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Sodium were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '>1 month', the abnormality criteria were '<127' mmol/L (Low) and '>151' mmol/L (High) of serum Sodium.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (Sodium) with markedly abnormal criteria specified at any visit.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
26.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Potassium)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Potassium were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '>=1 year', the abnormality criteria were '<= 3.0' mmol/L (Low) and '>= 6.0' mmol/L (High) of serum Potassium.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Week 2-High) wherein at least 1 TEMA value of Serum chemistry parameter (Potassium) observed during the study was reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 230
Measure Type: Number
Unit of Measure: percentage of participants
0.4
27.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Chloride were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '>1 month', the abnormality criteria were '<=90' mmol/L (Low) and '>=112' mmol/L (High) of serum Chloride.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of serum chemistry parameter (Chloride) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 234
Measure Type: Number
Unit of Measure: percentage of participants
High: Wk 2 (>1 m) Number Analyzed 234 participants
1.3
High: Wk 22 (>1 m) Number Analyzed 218 participants
2.3
High: Wk 46 (>1 m) Number Analyzed 198 participants
2.5
High: Wk 62 (>1 m) Number Analyzed 194 participants
1.5
High: Wk 78 (>1 m) Number Analyzed 65 participants
3.1
High: Wk 94 (>1 m) Number Analyzed 165 participants
1.2
High: Wk 118 (>1 m) Number Analyzed 145 participants
3.4
High: Wk 214 (>1 m) Number Analyzed 43 participants
2.3
High: TV (>1 m) Number Analyzed 145 participants
1.4
28.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Bicarbonate were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '>1 month-<17 years', the abnormality criteria were '<15' mmol/L (Low) and '>38' mmol/L (High). For age range, '>=17 years', the abnormality criteria were '<18' mmol/L (Low) and '>38' mmol/L (High) of serum Bicarbonate.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of serum chemistry parameter (Bicarbonate) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 180
Measure Type: Number
Unit of Measure: percentage of participants
Low: Wk 2 (>=17 y) Number Analyzed 180 participants
1.1
Low: Wk 46 (>=17 y) Number Analyzed 161 participants
1.2
Low: Wk 62 (>=17 y) Number Analyzed 158 participants
1.3
Low: Wk 94 (>=17 y) Number Analyzed 136 participants
0.7
29.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Creatinine)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Creatinine were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1-<10 years', the abnormality criteria were '>106.8' micromole per litre (umol/L), for '10-<16 years', the abnormality criteria were '>159.12' umol/L and for '>=16 years', the abnormality criteria was '>=176.8' umol/L for serum Creatinine.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (Creatinine) with markedly abnormal criteria specified at any visit.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
30.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Aspartate Aminotransferase (AST) were those that were observed post- BL during the Treatment Period but not present at Baseline. For all ages, the abnormality criteria were specified as '≥3.0 units per litre (U/L) x ULN' (High A), '≥5.0 U/L x ULN' (High B), and '≥10.0 U/L x ULN' (High C) of serum AST.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of serum chemistry parameter (AST) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
High A: All ages (Early TV) Number Analyzed 58 participants
1.7
High A: All ages (TV) Number Analyzed 144 participants
0.7
High B: All ages (TV) Number Analyzed 144 participants
0.7
High C: All ages (TV) Number Analyzed 144 participants
0.7
31.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Alanine Aminotransferase (ALT) were those that were observed post- BL during the Treatment Period but not present at Baseline. For all ages, the abnormality criteria were specified as '≥3.0 U/L x ULN' (High A), '≥5.0 U/L x ULN' (High B), and '≥10.0 U/L x ULN' (High C) of serum ALT.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of serum chemistry parameter (ALT) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 234
Measure Type: Number
Unit of Measure: percentage of participants
High A: All ages (Wk 2) Number Analyzed 234 participants
0.4
High A: All ages (Wk 46) Number Analyzed 198 participants
0.5
High A: All ages (Wk 62) Number Analyzed 192 participants
0.5
High A: All ages (Wk 118) Number Analyzed 144 participants
0.7
High A: All ages (TV) Number Analyzed 144 participants
0.7
High B: All ages (Wk 2) Number Analyzed 234 participants
0.4
32.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Chemistry Parameters (Total Bilirubin)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Total Bilirubin were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '>1 month', the abnormality criteria was '≥34.208' umol/L of serum Bilirubin.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Week 22) wherein at least 1 TEMA value of serum chemistry parameter (Total Bilirubin) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: percentage of participants
0.5
33.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alkaline Phosphatase)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Alkaline Phosphatase were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '4 years -<10 years', the abnormality criteria was '>=834 U/L', for '10 years -<17 years', the abnormality criteria was '>=1761 U/L' and for '>=17 years', the abnormality criteria was '>=3.0 U/L x ULN' of serum alkaline phosphatase.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (Alkaline Phosphatase) with markedly abnormal criteria specified at any visit .
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
34.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Gamma Glutamyl Transferase (GGT) were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year-<13 years', the abnormality criteria was '>=66' U/L (High A), for '13 years-<17 years', the abnormality criteria was '>=126' U/L (High B) and for '>=17 years', the abnormality criteria was '>=3.0 U/L x ULN' (High C) of serum GGT.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of serum chemistry parameter (GGT) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
High A: TV (1-<13 y) Number Analyzed 6 participants
16.7
High C: Wk 2 (>=17 y) Number Analyzed 198 participants
1.0
High C: Wk 22 (>=17 y) Number Analyzed 189 participants
0.5
High C: Wk 62 (>=17 y) Number Analyzed 169 participants
1.8
High C: Wk 78 (>=17 y) Number Analyzed 58 participants
3.4
High C: Wk 118 (>=17 y) Number Analyzed 125 participants
0.8
High C: Wk 166 (>=17 y) Number Analyzed 89 participants
1.1
High C:TV (>=17 y) Number Analyzed 132 participants
0.8
35.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Glucose were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '>1 month-<17 years', the abnormality criteria were from '<2.775' mmol/L (Low) and '>=9.99' mmol/L (High). For age range, '>=17 years', the abnormality criteria were '<2.775' mmol/L (Low) and '>=11.1' mmol/L (High) of serum Glucose.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of serum chemistry parameter (Glucose) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 195
Measure Type: Number
Unit of Measure: percentage of participants
Low: Wk 2 (>=17 y) Number Analyzed 195 participants
0.5
Low: Wk 62 (>=17 y) Number Analyzed 168 participants
0.6
Low: Wk 94 (>=17 y) Number Analyzed 143 participants
0.7
Low: Wk 118 (>=17 y) Number Analyzed 123 participants
0.8
High: Wk 2 (>=17 y) Number Analyzed 195 participants
1.0
High: Wk 22 (>=17 y) Number Analyzed 186 participants
1.1
High: Wk 46 (>=17 y) Number Analyzed 166 participants
1.2
High: Wk 62 (>=17 y) Number Analyzed 168 participants
1.8
High: Wk 78 (>=17 y) Number Analyzed 58 participants
3.4
High: Wk 94 (>=17 y) Number Analyzed 143 participants
0.7
High: Wk 118 (>=17 y) Number Analyzed 123 participants
0.8
High: Early TV (>=17 y) Number Analyzed 52 participants
1.9
36.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Albumin)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Albumin were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '>=1 year to <17 years', the abnormality criteria were '<24' g/L and '>84' g/L and for age range, '>=17 years', the abnormality criteria was '<26' g/L of serum albumin.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (Albumin) with markedly abnormal criteria specified at any visit.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
37.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Total Protein)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Total Protein were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year to <17 years', the abnormality criteria were '<43' g/L and '>120' g/L. For age range, '>=17 years', the abnormality criteria were '<43' g/L and '>130' g/L of serum protein.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (Total Protein) with markedly abnormal criteria specified at any visit.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
0
38.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Phosphate)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA laboratory results of Phosphate were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 year-<17 years', the abnormality criteria were from '<0.5814' mmol/L (Low) and '>2.3902' mmol/L (High). For age range, '>=17 years', the abnormality Criteria were '<=0.646' mmol/L (Low) and '>=1.938' mmol/L (High) of serum phosphate.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of serum chemistry parameter (Phosphate) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 141
Measure Type: Number
Unit of Measure: percentage of participants
Low: Wk 94 (>=17 y) Number Analyzed 141 participants
0.7
Low: Wk 118 (>=17 y) Number Analyzed 123 participants
0.8
39.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QT interval parameter were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 month (m)-<12 years', the abnormality criteria were '>=500 milliseconds (ms)' (Abnormal (Abn) A). For age range, '>=12 years', the abnormality criteria were '>=500 ms' (Abn B) or '>=60 ms increase from Baseline' (Abn C). The abnormality in QT interval was observed at Week 0 as the participant was rolled over from SP0982 study and was constantly having abnormal ECG parameters while in SP0982 and EP0012.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of ECG parameter (QT interval) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 216
Measure Type: Number
Unit of Measure: percentage of participants
Abn C: Wk 0 (>=12 years) Number Analyzed 3 participants
33.3
Abn C: Wk 2 (>=12 years) Number Analyzed 216 participants
0.5
Abn C: Wk 14 (>=12 years) Number Analyzed 209 participants
3.3
Abn C: Wk 30 (>=12 years) Number Analyzed 130 participants
0.8
Abn B: Wk 46 (>=12 years) Number Analyzed 188 participants
0.5
Abn C: Wk 46 (>=12 years) Number Analyzed 188 participants
2.7
Abn C: Wk 62 (>=12 years) Number Analyzed 186 participants
2.2
Abn C: Wk 78 (>=12 years) Number Analyzed 61 participants
1.6
Abn C: Wk 94 (>=12 years) Number Analyzed 162 participants
2.5
Abn C: Wk 118 (>=12 years) Number Analyzed 23 participants
13.0
Abn C: Wk 142 (>=12 years) Number Analyzed 58 participants
6.9
Abn C: Wk 190 (>=12 years) Number Analyzed 31 participants
3.2
Abn C: Early TV (>=12 years) Number Analyzed 52 participants
3.8
Abn C: TV (>=12 years) Number Analyzed 43 participants
2.3
40.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QTc(F) interval were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range '3 years -<12 years' and '>=12 years- <17 years', the abnormality criteria were from '>440 ms' (Abn A) and '>15% increase from Baseline' value (Abn B). For age range, '>=17 years', the abnormality Criteria were '>450 ms' (Abn C), '>480 ms' (Abn D), '>500 ms' (Abn E) or '>=60 ms increase from Baseline' value (Abn F). The abnormality in QTc(F) interval was observed at Week 0 as the participant was rolled over from SP0982 study and was constantly having abnormal ECG parameters while in SP0982 and EP0012.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of ECG parameter (QTc(F) interval) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
Abn C: Wk 0 (>=17 y) Number Analyzed 3 participants
33.3
Abn D: Wk 0 (>=17 y) Number Analyzed 3 participants
33.3
Abn F: Wk 0 (>=17 y) Number Analyzed 3 participants
33.3
Abn C: Wk 2 (>=17 y) Number Analyzed 196 participants
1.5
Abn F: Wk 2 (>=17 y) Number Analyzed 196 participants
1.0
Abn A: Wk 14 (>=12 y-<17 y) Number Analyzed 18 participants
5.6
Abn C: Wk 14 (>=17 y) Number Analyzed 191 participants
2.1
Abn D: Wk 14 (>=17 y) Number Analyzed 191 participants
1.0
Abn E: Wk 14 (>=17 y) Number Analyzed 191 participants
0.5
Abn F: Wk 14 (>=17 y) Number Analyzed 191 participants
3.7
Abn F: Wk 30 (>=17 y) Number Analyzed 118 participants
1.7
Abn C: Wk 46 (>=17 y) Number Analyzed 172 participants
5.2
Abn D: Wk 46 (>=17 y) Number Analyzed 172 participants
1.7
Abn E: Wk 46 (>=17 y) Number Analyzed 172 participants
1.2
Abn F: Wk 46 (>=17 y) Number Analyzed 172 participants
2.3
Abn A: Wk 62 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn B: Wk 62 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn C: Wk 62 (>=17 y) Number Analyzed 170 participants
2.4
Abn D: Wk 62 (>=17 y) Number Analyzed 170 participants
0.6
Abn F: Wk 62 (>=17 y) Number Analyzed 170 participants
1.8
Abn F: Wk 78 (>=17 y) Number Analyzed 56 participants
1.8
Abn C: Wk 94 (>=17 y) Number Analyzed 148 participants
2.7
Abn D: Wk 94 (>=17 y) Number Analyzed 148 participants
2.0
Abn E: Wk 94 (>=17 y) Number Analyzed 148 participants
2.0
Abn F: Wk 94 (>=17 y) Number Analyzed 148 participants
3.4
Abn C: Wk 118 (>=17 y) Number Analyzed 21 participants
9.5
Abn F: Wk 118 (>=17 y) Number Analyzed 21 participants
4.8
Abn C: Wk 142 (>=17 y) Number Analyzed 47 participants
2.1
Abn F: Wk 142 (>=17 y) Number Analyzed 47 participants
2.1
Abn C: Early TV (>=17 y) Number Analyzed 49 participants
6.1
Abn D: Early TV (>=17 y) Number Analyzed 49 participants
2.0
Abn E: Early TV (>=17 y) Number Analyzed 49 participants
2.0
Abn F: Early TV (>=17 y) Number Analyzed 49 participants
4.1
Abn C: TV (>=17 y) Number Analyzed 36 participants
2.8
Abn F: TV (>=17 y) Number Analyzed 36 participants
5.6
41.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QTc(B) interval were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range '3 years -<12 years' and '>=12 years- <17 years', the abnormality criteria were '>450 ms' (Abn A) and '>15% increase from Baseline' value (Abn B). For age range, '>=17 years', the abnormality criteria were '>450 ms' (Abn C), '>480 ms' (Abn D), '>500 ms' (Abn E) or '>=60 ms increase from Baseline' value (Abn F). The abnormality in QTc(B) interval was observed at Week 0 as the participant was rolled over from SP0982 study and was constantly having abnormal ECG parameters while in SP0982 and EP0012.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of ECG parameter (QTc(B) interval) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
Abn C: Wk 0 (>=17 y) Number Analyzed 3 participants
33.3
Abn D: Wk 0 (>=17 y) Number Analyzed 3 participants
33.3
Abn E: Wk 0 (>=17 y) Number Analyzed 3 participants
33.3
Abn F: Wk 0 (>=17 y) Number Analyzed 3 participants
33.3
Abn C: Wk 2 (>=17 y) Number Analyzed 196 participants
3.6
Abn F: Wk 2 (>=17 y) Number Analyzed 196 participants
2.0
Abn A: Wk 14 (>=12 y-<17 y) Number Analyzed 18 participants
5.6
Abn C: Wk 14 (>=17 y) Number Analyzed 191 participants
5.8
Abn D: Wk 14 (>=17 y) Number Analyzed 191 participants
1.6
Abn E: Wk 14 (>=17 y) Number Analyzed 191 participants
1.0
Abn F: Wk 14 (>=17 y) Number Analyzed 191 participants
3.7
Abn C: Wk 30 (>=17 y) Number Analyzed 118 participants
2.5
Abn F: Wk 30 (>=17 y) Number Analyzed 118 participants
1.7
Abn C: Wk 46 (>=17 y) Number Analyzed 172 participants
7.0
Abn D: Wk 46 (>=17 y) Number Analyzed 172 participants
2.9
Abn E: Wk 46 (>=17 y) Number Analyzed 172 participants
1.2
Abn F: Wk 46 (>=17 y) Number Analyzed 172 participants
3.5
Abn A: Wk 62 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn B: Wk 62 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn C: Wk 62 (>=17 y) Number Analyzed 170 participants
2.4
Abn D: Wk 62 (>=17 y) Number Analyzed 170 participants
0.6
Abn E: Wk 62 (>=17 y) Number Analyzed 170 participants
0.6
Abn F: Wk 62 (>=17 y) Number Analyzed 170 participants
3.5
Abn C: Wk 78 (>=17 y) Number Analyzed 56 participants
5.4
Abn F: Wk 78 (>=17 y) Number Analyzed 56 participants
1.8
Abn C: Wk 94 (>=17 y) Number Analyzed 148 participants
5.4
Abn D: Wk 94 (>=17 y) Number Analyzed 148 participants
2.0
Abn E: Wk 94 (>=17 y) Number Analyzed 148 participants
2.0
Abn F: Wk 94 (>=17 y) Number Analyzed 148 participants
3.4
Abn A: Wk 118 (>=12 y-<17 y) Number Analyzed 2 participants
50.0
Abn C: Wk 118 (>=17 y) Number Analyzed 21 participants
14.3
Abn D: Wk 118 (>=17 y) Number Analyzed 21 participants
4.8
Abn E: Wk 118 (>=17 y) Number Analyzed 21 participants
4.8
Abn F: Wk 118 (>=17 y) Number Analyzed 21 participants
9.5
Abn A: Wk 142 (>=12 y-<17 y) Number Analyzed 11 participants
9.1
Abn C: Wk 142 (>=17 y) Number Analyzed 47 participants
8.5
Abn F: Wk 142 (>=17 y) Number Analyzed 47 participants
4.3
Abn F: Wk 166 (>=17 y) Number Analyzed 3 participants
33.3
Abn C: Wk 190 (>=17 y) Number Analyzed 26 participants
7.7
Abn F: Wk 190 (>=17 y) Number Analyzed 26 participants
3.8
Abn C: Early TV (>=17 y) Number Analyzed 49 participants
6.1
Abn D: Early TV (>=17 y) Number Analyzed 49 participants
2.0
Abn E: Early TV (>=17 y) Number Analyzed 49 participants
2.0
Abn F: Early TV (>=17 y) Number Analyzed 49 participants
6.1
Abn C: TV (>=17 y) Number Analyzed 36 participants
2.8
Abn D: TV (>=17 y) Number Analyzed 36 participants
2.8
Abn F: TV (>=17 y) Number Analyzed 36 participants
5.6
42.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of PR interval were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -<12 years', the abnormality criteria were '>180 ms' (Abn A) and '>25% increase from Baseline' value (Abn B). For the age range, '>=12 years - <17 years', the abnormality criteria were '>200 ms' (Abn C) and '>25% increase from Baseline' value (Abn D). For age range, '>=17 years', the abnormality criteria were treatment-emergent values above '>200 ms' (Abn E), '>220 ms' (Abn F), or '>250 ms' (Abn G).
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of ECG parameter (PR interval) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
Abn B: Wk 2 (3 y-<12 y) Number Analyzed 16 participants
6.3
Abn D: Wk 2 (>=12 y-<17 y) Number Analyzed 20 participants
5.0
Abn E: Wk 2 (>=17 y) Number Analyzed 196 participants
1.5
Abn F: Wk 2 (>=17 y) Number Analyzed 196 participants
0.5
Abn E: Wk 14 (>=17 y) Number Analyzed 191 participants
1.0
Abn E: Wk 30 (>=17 y) Number Analyzed 117 participants
1.7
Abn F: Wk 30 (>=17 y) Number Analyzed 117 participants
0.9
Abn C: Wk 46 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn E: Wk 46 (>=17 y) Number Analyzed 172 participants
1.2
Abn B: Wk 62 (3 y-<12 y) Number Analyzed 10 participants
20.0
Abn C: Wk 62 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn E: Wk 62 (>=17 y) Number Analyzed 170 participants
2.9
Abn F: Wk 62 (>=17 y) Number Analyzed 170 participants
0.6
Abn E: Wk 78 (>=17 y) Number Analyzed 56 participants
5.4
Abn F: Wk 78 (>=17 y) Number Analyzed 56 participants
1.8
Abn G: Wk 78 (>=17 y) Number Analyzed 56 participants
1.8
Abn B: Wk 94 (3 y-<12 y) Number Analyzed 7 participants
28.6
Abn C: Wk 94 (>=12 y-<17 y) Number Analyzed 14 participants
7.1
Abn E: Wk 94 (>=17 y) Number Analyzed 148 participants
2.7
Abn F: Wk 94 (>=17 y) Number Analyzed 148 participants
0.7
Abn G: Wk 94 (>=17 y) Number Analyzed 148 participants
0.7
Abn D: Wk 118 (>=12 y-<17 y) Number Analyzed 2 participants
50.0
Abn E: Wk 142 (>=17 y) Number Analyzed 46 participants
8.7
Abn F: Wk 142 (>=17 y) Number Analyzed 46 participants
2.2
Abn E: Early TV (>=17 y) Number Analyzed 49 participants
2.0
Abn F: Early TV (>=17 y) Number Analyzed 49 participants
2.0
43.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of QRS interval were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -<12 years', the abnormality criteria were '>100 ms' (Abn A) and '>25% increase from Baseline' value (Abn B). For the age range, '>=12 years - <17 years', the abnormality criteria were '>110 ms' (Abn C) and '>25% increase from Baseline' (Abn D). For age range, '>=17 years', the abnormality criteria were treatment-emergent values above '>100 ms' (Abn E), '>120 ms' (Abn F), or '>140 ms' (Abn G).
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of ECG parameter (QRS interval) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
Abn E: Wk 2 (>=17 y) Number Analyzed 196 participants
5.1
Abn D: Wk 14 (>=12 y-<17 y) Number Analyzed 18 participants
5.6
Abn E: Wk 14 (>=17 y) Number Analyzed 191 participants
9.9
Abn F: Wk 14 (>=17 y) Number Analyzed 191 participants
0.5
Abn E: Wk 30 (>=17 y) Number Analyzed 118 participants
7.6
Abn A: Wk 46 (3 y-<12 y) Number Analyzed 12 participants
8.3
Abn D: Wk 46 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn E: Wk 46 (>=17 y) Number Analyzed 172 participants
7.6
Abn D: Wk 62 (>=12 y-<17 y) Number Analyzed 16 participants
6.3
Abn E: Wk 62 (>=17 y) Number Analyzed 170 participants
10.6
Abn F: Wk 62 (>=17 y) Number Analyzed 170 participants
1.8
Abn E: Wk 78 (>=17 y) Number Analyzed 56 participants
8.9
Abn F: Wk 78 (>=17 y) Number Analyzed 56 participants
1.8
Abn C: Wk 94 (>=12 y-<17 y) Number Analyzed 14 participants
7.1
Abn D: Wk 94 (>=12 y-<17 y) Number Analyzed 14 participants
7.1
Abn E: Wk 94 (>=17 y) Number Analyzed 148 participants
6.1
Abn F: Wk 94 (>=17 y) Number Analyzed 148 participants
0.7
Abn E: Wk 118 (>=17 y) Number Analyzed 21 participants
14.3
Abn E: Wk 142 (>=17 y) Number Analyzed 47 participants
10.6
Abn E: Early TV (>=17 y) Number Analyzed 49 participants
10.2
Abn E: TV (>=17 y) Number Analyzed 36 participants
5.6
Abn F: TV (>=17 y) Number Analyzed 36 participants
5.6
44.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA ECG results of Heart rate interval were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -<12 years', the abnormality criteria were '<60 beats per minute (bpm)' (Abn A) and '>130 bpm' (Abn B). For the age range, '>=12 years', the abnormality criteria were '<50 bpm' (Abn C) and '>120 bpm' (Abn D).
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of ECG parameter (Heart rate interval) observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 216
Measure Type: Number
Unit of Measure: percentage of participants
Abn C: Wk 2 (>=12 y) Number Analyzed 216 participants
1.4
Abn C: Wk 14 (>=12 y) Number Analyzed 209 participants
2.4
Abn C: Wk 30 (>=12 y) Number Analyzed 130 participants
1.5
Abn C: Wk 46 (>=12 y) Number Analyzed 188 participants
0.5
Abn D: Wk 46 (>=12 y) Number Analyzed 188 participants
0.5
Abn C: Wk 62 (>=12 y) Number Analyzed 186 participants
3.2
Abn D: Wk 62 (>=12 y) Number Analyzed 186 participants
0.5
Abn C: Wk 78 (>=12 y) Number Analyzed 61 participants
3.3
Abn C: Wk 94 (>=12 y) Number Analyzed 162 participants
1.2
Abn C: Wk 118 (>=12 y) Number Analyzed 23 participants
4.3
Abn D: Wk 214 (>=12 y) Number Analyzed 1 participants
100
Abn D: TV (>=12 y) Number Analyzed 43 participants
2.3
45.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA vital signs results of Pulse rate were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -<12 years', the abnormality criteria were '<60 bpm' (Low) and '>130 bpm' (High). For the age range, '12 years - <17 years', the abnormality criteria were '<=50 bpm' (Low) and '>=120 bpm' (High). For the age range, '>=17 years', the abnormality criteria were '<=50 bpm and a decrease from Baseline of >=15 bpm' (Low A), '>=120 bpm and an increase from Baseline of >=15 bpm' (High A), '<60 bpm' (Low B) and '>100 bpm' (High B). The Pulse rate was reported as per positions such as 'Supine 3 minute (Sup 3 min)', 'Standing 1 minute' (Std 1 min), and 'Standing 3 minute' (Std 3 min).
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Pulse rate observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
Low B: Wk 2 (>=17 y)-Sup 3 min Number Analyzed 199 participants
4.5
High B: Wk 2 (>=17 y)- Sup 3 min Number Analyzed 199 participants
0.5
High: Wk 2 (>=12 y-<17 y)-Std 1 min Number Analyzed 20 participants
5.0
Low B: Wk 2 (>=17 y)-Std 1 min Number Analyzed 197 participants
2.5
High B: Wk 2 (>=17 y)-Std 1 min Number Analyzed 197 participants
3.0
Low B: Wk 2 (>=17 y)-Std 3 min Number Analyzed 196 participants
1.5
High B: Wk 2 (>=17 y)-Std 3 min Number Analyzed 196 participants
2.6
Low A: Wk 6 (>=17 y)-Sup 3 min Number Analyzed 196 participants
0.5
Low B: Wk 6 (>=17 y)-Sup 3 min Number Analyzed 196 participants
4.6
High B: Wk 6 (>=17 y)-Sup 3 min Number Analyzed 196 participants
2.0
High: Wk 6 (>=12 y-<17 y)- Std 1 min Number Analyzed 21 participants
4.8
Low B: Wk 6 (>=17 y)- Std 1 min Number Analyzed 196 participants
1.5
High B: Wk 6 (>=17 y)- Std 1 min Number Analyzed 196 participants
3.1
Low A: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
0.5
Low B: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
1.0
High B: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
2.6
Low B: Wk 14 (>=17 y)- Sup 3 min Number Analyzed 196 participants
4.1
High B: Wk 14 (>=17 y)- Sup 3 min Number Analyzed 196 participants
1.0
High: Wk 14 (>=12 y-<17 y)- Std 1 min Number Analyzed 18 participants
5.6
Low B: Wk 14 (>=17 y)- Std 1 min Number Analyzed 195 participants
3.1
High B: Wk 14 (>=17 y)- Std 1 min Number Analyzed 195 participants
2.6
Low B: Wk 14 (>=17 y)- Std 3 min Number Analyzed 195 participants
0.5
High B: Wk 14 (>=17 y)- Std 3 min Number Analyzed 195 participants
4.1
Low B: Wk 22 (>=17 y)- Sup 3 min Number Analyzed 189 participants
3.2
High B: Wk 22 (>=17 y)- Sup 3 min Number Analyzed 189 participants
0.5
High A: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
0.5
Low B: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
1.6
High B: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
4.2
Low B: Wk 22 (>=17 y)- Std 3 min Number Analyzed 189 participants
2.1
High B: Wk 22 (>=17 y)- Std 3 min Number Analyzed 189 participants
3.7
Low B: Wk 30 (>=17 y)- Sup 3 min Number Analyzed 119 participants
1.7
Low B: Wk 30 (>=17 y)- Std 1 min Number Analyzed 119 participants
5.0
High B: Wk 30 (>=17 y)- Std 1 min Number Analyzed 119 participants
3.4
Low B: Wk 30 (>=17 y)- Std 3 min Number Analyzed 119 participants
2.5
High B: Wk 30 (>=17 y)- Std 3 min Number Analyzed 119 participants
1.7
Low B: Wk 38 (>=17 y)- Sup 3 min Number Analyzed 108 participants
3.7
Low B: Wk 38 (>=17 y)- Std 1 min Number Analyzed 107 participants
2.8
High B: Wk 38 (>=17 y)- Std 1 min Number Analyzed 107 participants
5.6
Low B: Wk 38 (>=17 y)- Std 3 min Number Analyzed 107 participants
0.9
High B: Wk 38 (>=17 y)- Std 3 min Number Analyzed 107 participants
2.8
Low B: Wk 46 (>=17 y)- Sup 3 min Number Analyzed 174 participants
5.7
High B: Wk 46 (>=17 y)- Sup 3 min Number Analyzed 174 participants
1.7
Low A: Wk 46 (>=17 y)- Std 1 min Number Analyzed 174 participants
0.6
High A: Wk 46 (>=17 y)- Std 1 min Number Analyzed 174 participants
1.1
Low B: Wk 46 (>=17 y)- Std 1 min Number Analyzed 174 participants
4.0
High B: Wk 46 (>=17 y)- Std 1 min Number Analyzed 174 participants
5.2
Low B: Wk 46 (>=17 y)- Std 3 min Number Analyzed 174 participants
2.9
High B: Wk 46 (>=17 y)- Std 3 min Number Analyzed 174 participants
4.6
Low B: Wk 62 (>=17 y)- Sup 3 min Number Analyzed 173 participants
5.2
High B: Wk 62 (>=17 y)- Sup 3 min Number Analyzed 173 participants
2.3
Low: Wk 62 (>=12 y-<17 y)- Std 1 min Number Analyzed 16 participants
6.3
High A: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
0.6
Low B: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
4.6
High B: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
4.0
High A: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
0.6
Low B: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
2.3
High B: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
2.9
Low B: Wk 78 (>=17 y)- Sup 3 min Number Analyzed 60 participants
6.7
High B: Wk 78 (>=17 y)- Sup 3 min Number Analyzed 60 participants
1.7
Low B: Wk 78 (>=17 y)- Std 1 min Number Analyzed 60 participants
6.7
High B: Wk 78 (>=17 y)- Std 1 min Number Analyzed 60 participants
6.7
Low B: Wk 78 (>=17 y)- Std 3 min Number Analyzed 60 participants
6.7
High B: Wk 78 (>=17 y)- Std 3 min Number Analyzed 60 participants
5.0
Low B: Wk 94 (>=17 y)- Sup 3 min Number Analyzed 148 participants
6.1
High B: Wk 94 (>=17 y)- Sup 3 min Number Analyzed 148 participants
0.7
Low B: Wk 94 (>=17 y)- Std 1 min Number Analyzed 148 participants
2.7
High B: Wk 94 (>=17 y)- Std 1 min Number Analyzed 148 participants
4.1
Low B: Wk 94 (>=17 y)- Std 3 min Number Analyzed 148 participants
1.4
High B: Wk 94 (>=17 y)- Std 3 min Number Analyzed 148 participants
2.7
Low B: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
2.2
High B: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
2.2
Low B: Wk 118 (>=17 y)- Std 1 min Number Analyzed 90 participants
2.2
High B: Wk 118 (>=17 y)- Std 1 min Number Analyzed 90 participants
3.3
Low B: Wk 118 (>=17 y)- Std 3 min Number Analyzed 90 participants
2.2
High B: Wk 118 (>=17 y)- Std 3 min Number Analyzed 90 participants
4.4
High A: Wk 142 (>=17 y)- Sup 3 min Number Analyzed 63 participants
1.6
Low B: Wk 142 (>=17 y)- Sup 3 min Number Analyzed 63 participants
6.3
High B: Wk 142 (>=17 y)- Sup 3 min Number Analyzed 63 participants
4.8
High A: Wk 142 (>=17 y)- Std 1 min Number Analyzed 63 participants
3.2
High B: Wk 142 (>=17 y)- Std 1 min Number Analyzed 63 participants
7.9
High A: Wk 142 (>=17 y)- Std 3 min Number Analyzed 63 participants
1.6
Low B: Wk 142 (>=17 y)- Std 3 min Number Analyzed 63 participants
3.2
High B: Wk 142 (>=17 y)- Std 3 min Number Analyzed 63 participants
7.9
Low B: Wk 166 (>=17 y)- Sup 3 min Number Analyzed 52 participants
3.8
High B: Wk 166 (>=17 y)- Sup 3 min Number Analyzed 52 participants
1.9
Low B: Wk 166 (>=17 y)- Std 1 min Number Analyzed 51 participants
2.0
High B: Wk 166 (>=17 y)- Std 1 min Number Analyzed 51 participants
5.9
High B: Wk 166 (>=17 y)- Std 3 min Number Analyzed 51 participants
5.9
Low B: Wk 190 (>=17 y)- Sup 3 min Number Analyzed 34 participants
2.9
High B: Wk 190 (>=17 y)- Sup 3 min Number Analyzed 34 participants
8.8
High B: Wk 190 (>=17 y)- Std 1 min Number Analyzed 34 participants
11.8
High B: Wk 190 (>=17 y)- Std 3 min Number Analyzed 34 participants
17.6
High B: Wk 214 (>=17 y)- Sup 3 min Number Analyzed 17 participants
5.9
High B: Wk 214 (>=17 y)- Std 1 min Number Analyzed 17 participants
5.9
High B: Wk 214 (>=17 y)- Std 3 min Number Analyzed 17 participants
5.9
Low B: Early TV (>=17 y)- Sup 3 min Number Analyzed 55 participants
3.6
High B: Early TV (>=17 y)- Sup 3 min Number Analyzed 55 participants
1.8
High: Early TV (>=12 y-<17 y)- Std 1 min Number Analyzed 3 participants
33.3
Low B: Early TV (>=17 y)- Std 1 min Number Analyzed 55 participants
3.6
High B: Early TV (>=17 y)- Std 1 min Number Analyzed 55 participants
5.5
Low A: TV (>=17 years)- Sup 3 min Number Analyzed 50 participants
2.0
Low B: TV (>=17 years)- Sup 3 min Number Analyzed 50 participants
4.0
High B: TV (>=17 years)- Sup 3 min Number Analyzed 50 participants
2.0
Low B: TV (>=17 years)- Std 1 min Number Analyzed 50 participants
2.0
High B: TV (>=17 years)- Std 1 min Number Analyzed 50 participants
4.0
Low B: TV (>=17 years)- Std 3 min Number Analyzed 50 participants
2.0
High B: TV (>=17 years)- Std 3 min Number Analyzed 50 participants
2.0
46.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Hide Description TEMA values of Systolic Blood Pressure (BP) results were those that were observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -<12 years', the abnormality criteria were '<80 millimeters of mercury (mmHg)' (Low) and '>140 mmHg' (High). For the age range, '>=12 years - <17 years', the abnormality criteria were '<90 mmHg' (Low) and '>160 mmHg' (High). For the age range, '>=17 years', the abnormality criteria were '<=90 mmHg and decrease from Baseline of >=20 mmHg' (Low A), '>=180 mmHg and increase from Baseline of >=20' mmHg (High A), '<90 mmHg' (Low B), '>140 mmHg (High B), and '>160 mmHg' (High C). Systolic BP were reported as per positions such as 'Sup 3 min', 'Std 1 min, and 'Std 3 min'.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Systolic BP observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
High B: Wk 2 (>=17 y)- Sup 3 min Number Analyzed 199 participants
3.5
Low B: Wk 2 (>=17 y)- Std 1 min Number Analyzed 197 participants
1.0
High B: Wk 2 (>=17 y)- Std 1 min Number Analyzed 197 participants
2.5
High B: Wk 2 (>=17 y)- Std 3 min Number Analyzed 196 participants
3.6
High B: Wk 6 (>=17 y)- Sup 3 min Number Analyzed 196 participants
3.1
High B: Wk 6 (>=17 y)- Std 1 min Number Analyzed 196 participants
2.0
Low B: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
0.5
High B: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
3.6
Low B: Wk 14 (>=17 y)- Sup 3 min Number Analyzed 196 participants
0.5
High B: Wk 14 (>=17 y)- Sup 3 min Number Analyzed 196 participants
3.1
High B: Wk 14 (>=17 y)- Std 1 min Number Analyzed 195 participants
3.6
High B: Wk 14 (>=17 y)- Std 3 min Number Analyzed 195 participants
3.6
High B: Wk 22 (>=17 y)- Sup 3 min Number Analyzed 189 participants
4.2
High B: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
4.2
High B: Wk 22 (>=17 y)- Std 3 min Number Analyzed 189 participants
3.7
Low B: Wk 30 (>=17 y)- Sup 3 min Number Analyzed 119 participants
0.8
High B: Wk 30 (>=17 y)- Sup 3 min Number Analyzed 119 participants
5.9
High B: Wk 30 (>=17 y)- Std 1 min Number Analyzed 119 participants
2.5
High B: Wk 30 (>=17 y)- Std 3 min Number Analyzed 119 participants
5.0
Low B: Wk 38 (>=17 y)- Sup 3 min Number Analyzed 108 participants
0.9
High B: Wk 38 (>=17 y)- Sup 3 min Number Analyzed 108 participants
2.8
Low B: Wk 38 (>=17 y)- Std 1 min Number Analyzed 107 participants
0.9
High B: Wk 38 (>=17 y)- Std 1 min Number Analyzed 107 participants
2.8
High B: Wk 38 (>=17 y)- Std 3 min Number Analyzed 107 participants
3.7
Low: Wk 46 (>=12 y-<17 y)- Sup 3 min Number Analyzed 16 participants
6.3
High B: Wk 46 (>=17 y)- Sup 3 min Number Analyzed 174 participants
2.9
Low: Wk 46 (>=12 y-<17 y)- Std 1 min Number Analyzed 16 participants
6.3
High B: Wk 46 (>=17 y)- Std 1 min Number Analyzed 174 participants
2.3
Low: Wk 46 (>=12 y-<17 y)- Std 3 min Number Analyzed 16 participants
6.3
High B: Wk 46 (>=17 y)- Std 3 min Number Analyzed 174 participants
3.4
High C: Wk 46 (>=17 y)- Std 3 min Number Analyzed 174 participants
0.6
Low B: Wk 62 (>=17 y)- Sup 3 min Number Analyzed 173 participants
0.6
High B: Wk 62 (>=17 y)- Sup 3 min Number Analyzed 173 participants
3.5
Low: Wk 62 (>=12 y-<17 y)- Std 1 min Number Analyzed 16 participants
6.3
Low A: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
0.6
Low B: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
0.6
High B: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
2.3
Low A: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
0.6
Low B: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
1.7
High B: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
1.2
Low A: Wk 78 (>=17 y)- Sup 3 min Number Analyzed 60 participants
1.7
High B: Wk 78 (>=17 y)- Sup 3 min Number Analyzed 60 participants
1.7
High B: Wk 78 (>=17 y)- Std 1 min Number Analyzed 60 participants
1.7
High B: Wk 78 (>=17 y)- Std 3 min Number Analyzed 60 participants
1.7
High B: Wk 94 (>=17 y)- Sup 3 min Number Analyzed 148 participants
4.1
High B: Wk 94 (>=17 y)- Std 1 min Number Analyzed 148 participants
4.1
High B: Wk 94 (>=17 y)- Std 3 min Number Analyzed 148 participants
4.1
High B: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
5.4
High C: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
1.1
High B: Wk 118 (>=17 y)- Std 1 min Number Analyzed 91 participants
5.5
High C: Wk 118 (>=17 y)- Std 1 min Number Analyzed 91 participants
1.1
High B: Wk 118 (>=17 y)- Std 3 min Number Analyzed 91 participants
6.6
High C: Wk 118 (>=17 y)- Std 3 min Number Analyzed 91 participants
1.1
High B: Wk 142 (>=17 y)- Sup 3 min Number Analyzed 63 participants
6.3
High B: Wk 142 (>=17 y)- Std 1 min Number Analyzed 63 participants
6.3
High B: Wk 142 (>=17 y)- Std 3 min Number Analyzed 63 participants
6.3
High B: Wk 166 (>=17 y)- Sup 3 min Number Analyzed 52 participants
3.8
High B: Wk 166 (>=17 y)- Std 1 min Number Analyzed 51 participants
7.8
High B: Wk 166 (>=17 y)- Std 3 min Number Analyzed 51 participants
7.8
High B: Wk 190 (>=17 y)- Sup 3 min Number Analyzed 34 participants
2.9
High B: Wk 214 (>=17 y)- Std 1 min Number Analyzed 17 participants
5.9
High C: Wk 214 (>=17 y)- Std 1 min Number Analyzed 17 participants
5.9
High B: Wk 214 (>=17 y)- Std 3 min Number Analyzed 17 participants
5.9
High B: Wk 262 (>=17 y)- Std 3 min Number Analyzed 1 participants
100
High B: Early TV (>=17 y)- Sup 3 min Number Analyzed 55 participants
1.8
High B: Early TV (>=17 y)- Std 1 min Number Analyzed 55 participants
1.8
High B: TV (>=17 y)- Std 1 min Number Analyzed 50 participants
4.0
High B: TV (>=17 y)- Std 3 min Number Analyzed 50 participants
2.0
47.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Hide Description TEMA values of Diastolic BP results were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range, '3 years -<12 years', the abnormality criteria were '<50 mmHg' (Low) and '>80 mmHg' (High), '>=12 years - <17 years', the abnormality criteria were '<=50 mmHg' (Low) and '>=105 mmHg' (High), and '>=17 years', the abnormality criteria were '<=50 mmHg and decrease from Baseline of >=15 mmHg' (Low A), '>=105 mmHg and increase from Baseline of >=15' mmHg (High A), '<50 mmHg' (Low B), '>90 mmHg' (High B), and '>100 mmHg' (High C). Diastolic BP were reported as per positions such as 'Sup 3 min', 'Std 1 min, and 'Std 3 min'.
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Diastolic BP observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
Low: Wk 2 (3 y-<12 y)- Sup 3 min Number Analyzed 16 participants
6.3
Low B: Wk 2 (>=17 y)- Sup 3 min Number Analyzed 199 participants
0.5
High B: Wk 2 (>=17 y)- Sup 3 min Number Analyzed 199 participants
2.5
Low: Wk 2 (3 y-<12 y)- Std 1 min Number Analyzed 16 participants
6.3
High: Wk 2 (3 y-<12 y)- Std 1 min Number Analyzed 16 participants
6.3
High B: Wk 2 (>=17 y)- Std 1 min Number Analyzed 197 participants
5.1
High C: Wk 2 (>=17 y)- Std 1 min Number Analyzed 197 participants
0.5
Low: Wk 2 (3 y-<12 y)- Std 3 min Number Analyzed 16 participants
6.3
High: Wk 2 (3 y-<12 y)- Std 3 min Number Analyzed 16 participants
12.5
High B: Wk 2 (>=17 y)- Std 3 min Number Analyzed 196 participants
6.1
High C: Wk 2 (>=17 y)- Std 3 min Number Analyzed 196 participants
0.5
Low A: Wk 6 (>=17 y)- Sup 3 min Number Analyzed 196 participants
0.5
High B: Wk 6 (>=17 y)- Sup 3 min Number Analyzed 196 participants
4.6
High C: Wk 6 (>=17 y)- Sup 3 min Number Analyzed 196 participants
0.5
Low A: Wk 6 (>=17 y)- Std 1 min Number Analyzed 196 participants
0.5
High A: Wk 6 (>=17 y)- Std 1 min Number Analyzed 196 participants
0.5
High B: Wk 6 (>=17 y)- Std 1 min Number Analyzed 196 participants
4.1
High C: Wk 6 (>=17 y)- Std 1 min Number Analyzed 196 participants
0.5
High: Wk 6 (3 y-<12 y)- Std 3 min Number Analyzed 14 participants
7.1
Low A: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
0.5
Low B: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
0.5
High B: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
6.6
High C: Wk 6 (>=17 y)- Std 3 min Number Analyzed 196 participants
0.5
High: Wk 14 (3 y-<12 y)- Sup 3 min Number Analyzed 13 participants
7.7
High B: Wk 14 (>=17 y)- Sup 3 min Number Analyzed 196 participants
2.0
High C: Wk 14 (>=17 y)- Sup 3 min Number Analyzed 196 participants
0.5
High A: Wk 14 (>=17 y)- Std 1 min Number Analyzed 195 participants
0.5
High B: Wk 14 (>=17 y)- Std 1 min Number Analyzed 195 participants
3.1
High C: Wk 14 (>=17 y)- Std 1 min Number Analyzed 195 participants
1.0
High: Wk 14 (3 y-<12 y)- Std 3 min Number Analyzed 12 participants
8.3
High B: Wk 14 (>=17 y)- Std 3 min Number Analyzed 195 participants
4.6
High C: Wk 14 (>=17 y)- Std 3 min Number Analyzed 195 participants
0.5
High: Wk 22 (3 y-<12 y)- Sup 3 min Number Analyzed 13 participants
15.4
Low: Wk 22 (>=12 y-<17 y)- Sup 3 min Number Analyzed 16 participants
6.3
High B: Wk 22 (>=17 y)- Sup 3 min Number Analyzed 189 participants
1.6
High C: Wk 22 (>=17 y)- Sup 3 min Number Analyzed 189 participants
0.5
High: Wk 22 (3 y-<12 y)- Std 1 min Number Analyzed 13 participants
15.4
Low A: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
1.1
Low B: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
0.5
High B: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
7.9
High C: Wk 22 (>=17 y)- Std 1 min Number Analyzed 189 participants
0.5
High: Wk 22 (3 y-<12 y)- Std 3 min Number Analyzed 13 participants
7.7
Low A: Wk 22 (>=17 y)- Std 3 min Number Analyzed 189 participants
0.5
High B: Wk 22 (>=17 y)- Std 3 min Number Analyzed 189 participants
6.3
High C: Wk 22 (>=17 y)- Std 3 min Number Analyzed 189 participants
1.1
High B: Wk 30 (>=17 y)- Sup 3 min Number Analyzed 119 participants
3.4
High C: Wk 30 (>=17 y)- Sup 3 min Number Analyzed 119 participants
0.8
High: Wk 30 (3 y-<12 y)- Std 1 min Number Analyzed 7 participants
14.3
High A: Wk 30 (>=17 y)- Std 1 min Number Analyzed 119 participants
0.8
High B: Wk 30 (>=17 y)- Std 1 min Number Analyzed 119 participants
5.9
High C: Wk 30 (>=17 y)- Std 1 min Number Analyzed 119 participants
0.8
High B: Wk 30 (>=17 y)- Std 3 min Number Analyzed 119 participants
4.2
High B: Wk 38 (>=17 y)- Sup 3 min Number Analyzed 108 participants
2.8
High: Wk 38 (3 y-<12 y)- Std 1 min Number Analyzed 5 participants
20.0
High B: Wk 38 (>=17 y)- Std 1 min Number Analyzed 107 participants
5.6
High C: Wk 38 (>=17 y)- Std 1 min Number Analyzed 107 participants
0.9
High B: Wk 38 (>=17 y)- Std 3 min Number Analyzed 107 participants
9.3
Low A: Wk 46 (>=17 y)- Sup 3 min Number Analyzed 174 participants
0.6
High B: Wk 46 (>=17 y)- Sup 3 min Number Analyzed 174 participants
4.0
Low: Wk 46 (>=12 y-<17 y)- Std 1 min Number Analyzed 16 participants
6.3
High B: Wk 46 (>=17 y)- Std 1 min Number Analyzed 174 participants
8.0
High C: Wk 46 (>=17 y)- Std 1 min Number Analyzed 174 participants
0.6
High B: Wk 46 (>=17 y)- Std 3 min Number Analyzed 174 participants
9.8
High C: Wk 46 (>=17 y)- Std 3 min Number Analyzed 174 participants
1.1
High A: Wk 62 (>=17 y)- Sup 3 min Number Analyzed 173 participants
0.6
High B: Wk 62 (>=17 y)- Sup 3 min Number Analyzed 173 participants
5.2
High C: Wk 62 (>=17 y)- Sup 3 min Number Analyzed 173 participants
1.2
High: Wk 62 (3 y-<12 y)- Std 1 min Number Analyzed 10 participants
20.0
Low: Wk 62 (>=12 y-<17 y)- Std 1 min Number Analyzed 16 participants
6.3
High A: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
0.6
High B: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
5.8
High C: Wk 62 (>=17 y)- Std 1 min Number Analyzed 173 participants
1.2
Low B: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
0.6
High B: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
5.8
High C: Wk 62 (>=17 y)- Std 3 min Number Analyzed 173 participants
0.6
Low: Wk 78 (>=12 y-<17 y)- Sup 3 min Number Analyzed 6 participants
16.7
High B: Wk 78 (>=17 y)- Sup 3 min Number Analyzed 60 participants
1.7
High B: Wk 78 (>=17 y)- Std 1 min Number Analyzed 60 participants
3.3
High B: Wk 78 (>=17 y)- Std 3 min Number Analyzed 60 participants
3.3
High C: Wk 78 (>=17 y)- Std 3 min Number Analyzed 60 participants
1.7
High B: Wk 94 (>=17 y)- Sup 3 min Number Analyzed 148 participants
1.4
High B: Wk 94 (>=17 y)- Std 1 min Number Analyzed 148 participants
4.1
High: Wk 94 (3 y-<12 y)- Std 3 min Number Analyzed 7 participants
14.3
High A: Wk 94 (>=17 y)- Std 3 min Number Analyzed 148 participants
0.7
High B: Wk 94 (>=17 y)- Std 3 min Number Analyzed 148 participants
4.7
High C: Wk 94 (>=17 y)- Std 3 min Number Analyzed 148 participants
0.7
Low A: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
1.1
High A: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
1.1
Low B: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
1.1
High B: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
2.2
High C: Wk 118 (>=17 y)- Sup 3 min Number Analyzed 92 participants
1.1
Low A: Wk 118 (>=17 y)- Std 1 min Number Analyzed 91 participants
1.1
Low B: Wk 118 (>=17 y)- Std 1 min Number Analyzed 91 participants
1.1
High B: Wk 118 (>=17 y)- Std 1 min Number Analyzed 91 participants
4.4
High B: Wk 118 (>=17 y)- Std 3 min Number Analyzed 91 participants
7.7
High B: Wk 142 (>=17 y)- Sup 3 min Number Analyzed 63 participants
6.3
High B: Wk 142 (>=17 y)- Std 1 min Number Analyzed 63 participants
7.9
High B: Wk 142 (>=17 y)- Std 3 min Number Analyzed 63 participants
7.9
High B: Wk 166 (>=17 y)- Sup 3 min Number Analyzed 52 participants
3.8
High B: Wk 166 (>=17 y)- Std 1 min Number Analyzed 51 participants
5.9
High A: Wk 166 (>=17 y)- Std 3 min Number Analyzed 51 participants
2.0
High B: Wk 166 (>=17 y)- Std 3 min Number Analyzed 51 participants
11.8
High C: Wk 166 (>=17 y)- Std 3 min Number Analyzed 51 participants
2.0
High B: Wk 190 (>=17 y)- Std 3 min Number Analyzed 34 participants
2.9
High B: Wk 214 (>=17 y)- Sup 3 min Number Analyzed 17 participants
5.9
High A: Wk 214 (>=17 y)- Std 1 min Number Analyzed 17 participants
5.9
High B: Wk 214 (>=17 y)- Std 1 min Number Analyzed 17 participants
5.9
High C: Wk 214 (>=17 y)- Std 1 min Number Analyzed 17 participants
5.9
High A: Wk 214 (>=17 y)- Std 3 min Number Analyzed 17 participants
5.9
High B: Wk 214 (>=17 y)- Std 3 min Number Analyzed 17 participants
5.9
High C: Wk 214 (>=17 y)- Std 3 min Number Analyzed 17 participants
5.9
High B: Early TV (>=17 y)- Sup 3 min Number Analyzed 55 participants
3.6
High C: Early TV (>=17 y)- Sup 3 min Number Analyzed 55 participants
1.8
High B: Early TV (>=17 y)- Std 1 min Number Analyzed 55 participants
9.1
High C: Early TV (>=17 y)- Std 1 min Number Analyzed 55 participants
1.8
High A: Early TV (>=17 y)- Std 3 min Number Analyzed 55 participants
1.8
High B: Early TV (>=17 y)- Std 3 min Number Analyzed 55 participants
10.9
High C: Early TV (>=17 y)- Std 3 min Number Analyzed 55 participants
3.6
High: TV (3 y-<12 y)- Sup 3 min Number Analyzed 6 participants
16.7
High B: TV (>=17 y)- Sup 3 min Number Analyzed 50 participants
4.0
High B: TV (>=17 y)- Std 1 min Number Analyzed 50 participants
2.0
High B: TV (>=17 y)- Std 3 min Number Analyzed 50 participants
4.0
High C: TV (>=17 y)- Std 3 min Number Analyzed 50 participants
2.0
48.Secondary Outcome
Title Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Hide Description TEMA values are defined in the SAP as significant deviations from the expected range of age-appropriate values. TEMA vital signs parameter results were those that are observed post- BL during the Treatment Period but not present at Baseline. For the age range, '1 month - <17 years', the abnormality criteria were '<3% of normal body weight' in Kilograms (kg) or '>97% of normal body weight' in kgs. Here, '<3% of normal' is presented as 'Low' and '>97% of normal' is presented as 'High'. For the age range '>=17 years', the abnormality criteria were 'Increase/decrease of >=10%' body weight in kgs (presented as Inc/Dec A) or 'Increase/decrease of >=7%' body weight in kgs (presented as Inc/Dec B).
Time Frame During the study (up to approximately 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA body weight value observed during the study were reported in this assessment.
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description:
Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: percentage of participants
High- Wk 14 (1 m - <17 y) Number Analyzed 31 participants
9.7
Inc/Dec A- Wk 14 (>=17 y) Number Analyzed 195 participants
5.6
Inc/Dec B- Wk 14 (>=17 y) Number Analyzed 195 participants
16.4
High- Wk 30 (1 m - <17 y) Number Analyzed 19 participants
10.5
Inc/Dec A- Wk 30 (>=17 y) Number Analyzed 119 participants
5.9
Inc/Dec B- Wk 30 (>=17 y) Number Analyzed 119 participants
19.3
High- Wk 46 (1 m - <17 y) Number Analyzed 28 participants
7.1
Inc/Dec A- Wk 46 (>=17 y) Number Analyzed 177 participants
12.4
Inc/Dec B- Wk 46 (>=17 y) Number Analyzed 177 participants
22.6
High- Wk 62 (1 m - <17 y) Number Analyzed 26 participants
7.7
Inc/Dec A- Wk 62 (>=17 y) Number Analyzed 174 participants
14.9
Inc/Dec B- Wk 62 (>=17 y) Number Analyzed 174 participants
21.8
Inc/Dec A- Wk 78 (>=17 y) Number Analyzed 63 participants
19.0
Inc/Dec B- Wk 78 (>=17 y) Number Analyzed 63 participants
30.2
High- Wk 94 (1 m - <17 y) Number Analyzed 23 participants
13.0
Inc/Dec A- Wk 94 (>=17 y) Number Analyzed 152 participants
16.4
Inc/Dec B- Wk 94 (>=17 y) Number Analyzed 152 participants
30.9
Low- Wk 118 (1 m - <17 y) Number Analyzed 19 participants
5.3
High- Wk 118 (1 m - <17 y) Number Analyzed 19 participants
10.5
Inc/Dec A- Wk 118 (>=17 y) Number Analyzed 97 participants
21.6
Inc/Dec B- Wk 118 (>=17 y) Number Analyzed 97 participants
33.0
Low- Wk 142 (1 m - <17 y) Number Analyzed 13 participants
7.7
High- Wk 142 (1 m - <17 y) Number Analyzed 13 participants
7.7
Inc/Dec A- Wk 142 (>=17 y) Number Analyzed 77 participants
19.5
Inc/Dec B- Wk 142 (>=17 y) Number Analyzed 77 participants
32.5
High- Wk 166 (1 m - <17 y) Number Analyzed 10 participants
10.0
Inc/Dec A- Wk 166 (>=17 y) Number Analyzed 60 participants
25.0
Inc/Dec B- Wk 166 (>=17 y) Number Analyzed 60 participants
45.0
Low- Wk 190 (1 m - <17 y) Number Analyzed 6 participants
16.7
Inc/Dec A- Wk 190 (>=17 y) Number Analyzed 46 participants
26.1
Inc/Dec B- Wk 190 (>=17 y) Number Analyzed 46 participants
50.0
Low- Wk 214 (1 m - <17 y) Number Analyzed 2 participants
50.0
Inc/Dec A- Wk 214 (>=17 y) Number Analyzed 22 participants
31.8
Inc/Dec B- Wk 214 (>=17 y) Number Analyzed 22 participants
54.5
Inc/Dec A- Wk 238 (>=17 y) Number Analyzed 6 participants
16.7
Inc/Dec B- Wk 238 (>=17 y) Number Analyzed 6 participants
50.0
Inc/Dec A- Wk 262 (>=17 y) Number Analyzed 3 participants
33.3
Inc/Dec B- Wk 262 (>=17 y) Number Analyzed 3 participants
33.3
Inc/Dec A- Early TV (>=17 y) Number Analyzed 57 participants
26.3
Inc/Dec B- Early TV (>=17 y) Number Analyzed 57 participants
33.3
High- TV (1 m - <17 y) Number Analyzed 14 participants
21.4
Inc/Dec A- TV (>=17 y) Number Analyzed 55 participants
34.5
Inc/Dec B- TV (>=17 y) Number Analyzed 55 participants
52.7
49.Secondary Outcome
Title Percent Change in Primary Generalized Tonic-clonic Seizure (PGTCS) Frequency Per 28 Days From Combined Baseline
Hide Description The 28-day PGTCS frequency during the relative period was subtracted from the 28-day Combined Baseline PGTCS frequency and the result was divided by 28-day Combined Baseline PGTCS frequency and the result was then multiplied by 100 to get percent change in PGTCS frequency per 28 days from Combined Baseline Period (CB) to the appropriate analysis Period. The CB was defined as the combined 12-week Historical Baseline and 4-week Prospective Baseline periods immediately prior to randomization in the study SP0982 or prior to Visit 1 (first dose) if direct enrollers in EP0012.
Time Frame From Combined Baseline until end of Treatment Period (up to approximately 5 years)
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Hide Analysis Population Description
Full Analysis Set (FAS) was a subset of the Safety Set and included all study participants with seizure diary data for at least 1 day during this study.
Arm/Group Title All Participants (Lacosamide)
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Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
Overall Number of Participants Analyzed 238
Median (Full Range)
Unit of Measure: percent change
-88.58
(-100.0 to 465.4)
Time Frame From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Adverse Event Reporting Description AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. TEAEs were assessed on SS.
 
Arm/Group Title All Participants (Lacosamide)
Hide Arm/Group Description Participants included in this treatment group received at least one dose of LCM as EP0012 protocol entry criteria. The dose range for pediatric participants weighing <50 kg is from 4 mg/kg/day (oral solution) to 12 mg/kg/day (oral solution), for pediatric participants weighing ≥50 kg, the dose range is from 200 mg/day (tablets) to 600 mg/day (tablets) and for adult participants, the dose range is from 200 mg/day to 800mg/day (tablets) during the Treatment Period. The LCM dose may be increased or decreased at the investigator's discretion after the study participant received the first dose of LCM in the study. Pediatric participants who initially started on oral solution might have transferred to tablets at Investigator's discretion after achieving >=50 kgs. LCM was administered orally, twice daily (bid), up to approximately 5 years. Treatment was continued for at least 2 years for adult participants and up to approximately 5 years for pediatric participants.
All-Cause Mortality
All Participants (Lacosamide)
Affected / at Risk (%)
Total   4/239 (1.67%)    
Hide Serious Adverse Events
All Participants (Lacosamide)
Affected / at Risk (%) # Events
Total   54/239 (22.59%)    
Cardiac disorders   
Cardiac failure * 1  1/239 (0.42%)  1
Cardiac failure acute * 1  1/239 (0.42%)  1
Myocardial infarction * 1  1/239 (0.42%)  1
Ear and labyrinth disorders   
Vertigo positional * 1  1/239 (0.42%)  1
Eye disorders   
Diplopia * 1  1/239 (0.42%)  1
Periorbital oedema * 1  1/239 (0.42%)  1
Gastrointestinal disorders   
Vomiting * 1  2/239 (0.84%)  2
Abdominal pain * 1  1/239 (0.42%)  1
Abdominal pain lower * 1  1/239 (0.42%)  1
Coeliac disease * 1  1/239 (0.42%)  1
Small intestinal perforation * 1  1/239 (0.42%)  1
General disorders   
Death * 1  1/239 (0.42%)  1
Drowning * 1  1/239 (0.42%)  1
Non-cardiac chest pain * 1  1/239 (0.42%)  1
Infections and infestations   
Escherichia urinary tract infection * 1  1/239 (0.42%)  1
Infected dermal cyst * 1  1/239 (0.42%)  1
Otitis media acute * 1  1/239 (0.42%)  1
Urinary tract infection * 1  1/239 (0.42%)  1
Viral upper respiratory tract infection * 1  1/239 (0.42%)  1
Injury, poisoning and procedural complications   
Head injury * 1  2/239 (0.84%)  4
Facial bones fracture * 1  2/239 (0.84%)  2
Subdural haematoma * 1  2/239 (0.84%)  2
Animal bite * 1  1/239 (0.42%)  1
Ankle fracture * 1  1/239 (0.42%)  1
Clavicle fracture * 1  1/239 (0.42%)  1
Epidural haemorrhage * 1  1/239 (0.42%)  1
Face injury * 1  1/239 (0.42%)  1
Fall * 1  1/239 (0.42%)  1
Fibula fracture * 1  1/239 (0.42%)  1
Fracture * 1  1/239 (0.42%)  1
Hand fracture * 1  1/239 (0.42%)  1
Intentional overdose * 1  1/239 (0.42%)  1
Lip injury * 1  1/239 (0.42%)  1
Periorbital contusion * 1  1/239 (0.42%)  1
Spinal column injury * 1  1/239 (0.42%)  1
Stab wound * 1  1/239 (0.42%)  1
Toxicity to various agents * 1  1/239 (0.42%)  1
Traumatic intracranial haemorrhage * 1  1/239 (0.42%)  1
Investigations   
Drug level increased * 1  1/239 (0.42%)  1
Weight decreased * 1  1/239 (0.42%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/239 (0.42%)  1
Diabetes mellitus * 1  1/239 (0.42%)  1
Musculoskeletal and connective tissue disorders   
Mixed connective tissue disease * 1  1/239 (0.42%)  1
Osteoarthritis * 1  1/239 (0.42%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer * 1  1/239 (0.42%)  2
Uterine leiomyoma * 1  1/239 (0.42%)  1
Nervous system disorders   
Grand mal convulsion * 1  16/239 (6.69%)  20
Status epilepticus * 1  4/239 (1.67%)  7
Myoclonic epilepsy * 1  2/239 (0.84%)  2
Petit mal epilepsy * 1  1/239 (0.42%)  2
Benign intracranial hypertension * 1  1/239 (0.42%)  1
Brain injury * 1  1/239 (0.42%)  1
Convulsion * 1  1/239 (0.42%)  1
Cubital tunnel syndrome * 1  1/239 (0.42%)  1
Dizziness * 1  1/239 (0.42%)  1
Migraine * 1  1/239 (0.42%)  1
Multiple sclerosis relapse * 1  1/239 (0.42%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/239 (0.42%)  1
Psychiatric disorders   
Suicide attempt * 1  2/239 (0.84%)  2
Completed suicide * 1  1/239 (0.42%)  1
Mental status changes * 1  1/239 (0.42%)  1
Psychogenic seizure * 1  1/239 (0.42%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration * 1  2/239 (0.84%)  2
Acute respiratory failure * 1  1/239 (0.42%)  1
Respiratory failure * 1  1/239 (0.42%)  1
Vascular disorders   
Peripheral ischaemia * 1  1/239 (0.42%)  1
1
Term from vocabulary, MedDRA v16.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants (Lacosamide)
Affected / at Risk (%) # Events
Total   176/239 (73.64%)    
Ear and labyrinth disorders   
Vertigo * 1  19/239 (7.95%)  30
Eye disorders   
Diplopia * 1  12/239 (5.02%)  15
Gastrointestinal disorders   
Nausea * 1  23/239 (9.62%)  31
Diarrhoea * 1  18/239 (7.53%)  23
Vomiting * 1  16/239 (6.69%)  24
General disorders   
Fatigue * 1  13/239 (5.44%)  15
Pyrexia * 1  13/239 (5.44%)  13
Infections and infestations   
Nasopharyngitis * 1  52/239 (21.76%)  91
Influenza * 1  18/239 (7.53%)  23
Upper respiratory tract infection * 1  17/239 (7.11%)  18
Corona virus infection * 1  14/239 (5.86%)  16
Injury, poisoning and procedural complications   
Contusion * 1  24/239 (10.04%)  30
Laceration * 1  12/239 (5.02%)  14
Musculoskeletal and connective tissue disorders   
Back pain * 1  17/239 (7.11%)  19
Nervous system disorders   
Headache * 1  56/239 (23.43%)  113
Dizziness * 1  53/239 (22.18%)  73
Somnolence * 1  40/239 (16.74%)  51
Grand mal convulsion * 1  14/239 (5.86%)  16
Migraine * 1  13/239 (5.44%)  17
1
Term from vocabulary, MedDRA v16.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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
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Name/Title: UCB
Organization: Cares
Phone: 001 844 599 2273
EMail: UCBCares@ucb.com
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Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT02408549    
Other Study ID Numbers: EP0012
2012-001770-29 ( EudraCT Number )
First Submitted: March 31, 2015
First Posted: April 3, 2015
Results First Submitted: September 28, 2023
Results First Posted: December 14, 2023
Last Update Posted: December 14, 2023