Trial Outcomes & Findings for Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures (NCT NCT02408549)
NCT ID: NCT02408549
Last Updated: 2023-12-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
239 participants
Primary outcome timeframe
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Results posted on
2023-12-14
Participant Flow
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.
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.
Participant milestones
| Measure |
All Participants (Lacosamide)
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.
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|---|---|
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Overall Study
STARTED
|
239
|
|
Overall Study
COMPLETED
|
157
|
|
Overall Study
NOT COMPLETED
|
82
|
Reasons for withdrawal
| Measure |
All Participants (Lacosamide)
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.
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|---|---|
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Overall Study
Adverse Event
|
15
|
|
Overall Study
Death
|
4
|
|
Overall Study
Lack of Efficacy
|
17
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Consent withdrawn
|
30
|
|
Overall Study
Neurology research program closing at site
|
1
|
|
Overall Study
Site closure
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Withdrawal of consent due to business trip
|
1
|
|
Overall Study
Subject moved to another place, far from site
|
1
|
|
Overall Study
Study terminated at site
|
1
|
Baseline Characteristics
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
Baseline characteristics by cohort
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
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|---|---|
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Age, Continuous
|
27.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Age, Customized
≥4-<12 years
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16 Participants
n=5 Participants
|
|
Age, Customized
12-<18 years
|
28 Participants
n=5 Participants
|
|
Age, Customized
18-<65 years
|
194 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
178 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
211 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)Population: The Safety Set included all study participants who received at least 1 dose of IMP during this study.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
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|---|---|
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Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period
|
222 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)Population: The Safety Set included all study participants who received at least 1 dose of IMP during this study.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
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|---|---|
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Number of Study Participants Withdrawn Due to TEAEs
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19 Participants
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PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)Population: The Safety Set included all study participants who received at least 1 dose of IMP during this study.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
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|---|---|
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Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
Absence seizures
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3 Participants
|
|
Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
Myoclonic seizures
|
5 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=93 Participants
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.
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|---|---|
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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)
|
5 Participants
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PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=93 Participants
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.
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|---|---|
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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)
|
1 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=93 Participants
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.
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|---|---|
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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)
|
0 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=93 Participants
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.
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|---|---|
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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)
|
0 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=96 Participants
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.
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|---|---|
|
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)
|
4 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=96 Participants
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.
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|---|---|
|
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)
|
1 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=96 Participants
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.
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|---|---|
|
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)
|
1 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline PeriodPopulation: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=96 Participants
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.
|
|---|---|
|
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)
|
2 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)Population: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=92 Participants
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.
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|---|---|
|
Percentage of Study Participants With at Least 50% Worsening in Days With Absence Seizures
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)Population: 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).
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=95 Participants
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.
|
|---|---|
|
Percentage of Study Participants With at Least 50% Worsening in Days With Myoclonic Seizures
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Low: Week (Wk) 78 (2-<17 y)
|
14.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Low: Wk 0 (>=17 y)
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Low: Wk 2 (>=17 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Low: Wk 118 (>=17 y)
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Low: Wk 166 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Low: Wk 214 (>=17 y)
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Low: Termination Visit (TV) (>=17 y)
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
High: Wk 22 (2-<17 y)
|
6.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
High: Wk 46 (2-<17 y)
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
Low: Wk 46 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
Low: Wk 118 (>=17 y)
|
1.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
Low: Wk 166 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
Low: TV (>=17 y)
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Platelets)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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).
Outcome measures
| Measure |
All Participants (Lacosamide)
n=59 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Erythrocytes)
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=191 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Leukocytes)
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=228 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Basophils Absolute)
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=228 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute)
>=1.0: Wk 2 (>1 month)
|
0.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute)
>=1.0: Wk 22 (>1 month)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute)
>=1.0: TV (>1 month)
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=226 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Lymphocytes Absolute)
High: Wk 2 (>=6 y)
|
0.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Lymphocytes Absolute)
High: Wk 78 (>=6 y)
|
3.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Lymphocytes Absolute)
High: Wk 118 (>=6 y)
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Monocytes Absolute )
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=228 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
<1.5: Wk 2 (>1 m)
|
0.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
<1.5: Wk 22 (>1 m)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
<1.5: Wk 46 (>1 m)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
<1.5: Wk 62 (>1 m)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
<1.5: Wk 94 (>1 m)
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
<1.5: Wk 214 (>1 m)
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Calcium)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Sodium)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=230 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Potassium)
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=234 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 2 (>1 m)
|
1.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 22 (>1 m)
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 46 (>1 m)
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 62 (>1 m)
|
1.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 78 (>1 m)
|
3.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 94 (>1 m)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 118 (>1 m)
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: Wk 214 (>1 m)
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
High: TV (>1 m)
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=180 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
Low: Wk 2 (>=17 y)
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
Low: Wk 46 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
Low: Wk 62 (>=17 y)
|
1.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
Low: Wk 94 (>=17 y)
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Creatinine)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
High A: All ages (Early TV)
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
High A: All ages (TV)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
High B: All ages (TV)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
High C: All ages (TV)
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=234 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
High A: All ages (Wk 2)
|
0.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
High A: All ages (Wk 46)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
High A: All ages (Wk 62)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
High A: All ages (Wk 118)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
High A: All ages (TV)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
High B: All ages (Wk 2)
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=218 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Chemistry Parameters (Total Bilirubin)
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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 .
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alkaline Phosphatase)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High A: TV (1-<13 y)
|
16.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High C: Wk 2 (>=17 y)
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High C: Wk 22 (>=17 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High C: Wk 62 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High C: Wk 78 (>=17 y)
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High C: Wk 118 (>=17 y)
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High C: Wk 166 (>=17 y)
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
High C:TV (>=17 y)
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=195 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Early TV (>=17 y)
|
1.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
Low: Wk 2 (>=17 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
Low: Wk 62 (>=17 y)
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
Low: Wk 94 (>=17 y)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
Low: Wk 118 (>=17 y)
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Wk 2 (>=17 y)
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Wk 22 (>=17 y)
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Wk 46 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Wk 62 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Wk 78 (>=17 y)
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Wk 94 (>=17 y)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
High: Wk 118 (>=17 y)
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Albumin)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Total Protein)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=141 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Phosphate)
Low: Wk 94 (>=17 y)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Phosphate)
Low: Wk 118 (>=17 y)
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=216 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 0 (>=12 years)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 2 (>=12 years)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 14 (>=12 years)
|
3.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 30 (>=12 years)
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn B: Wk 46 (>=12 years)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 46 (>=12 years)
|
2.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 62 (>=12 years)
|
2.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 78 (>=12 years)
|
1.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 94 (>=12 years)
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 118 (>=12 years)
|
13.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 142 (>=12 years)
|
6.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Wk 190 (>=12 years)
|
3.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: Early TV (>=12 years)
|
3.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Abn C: TV (>=12 years)
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn D: Wk 94 (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 118 (>=17 y)
|
9.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn D: Early TV (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 0 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn D: Wk 0 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 0 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 2 (>=17 y)
|
1.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 2 (>=17 y)
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn A: Wk 14 (>=12 y-<17 y)
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 14 (>=17 y)
|
2.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn D: Wk 14 (>=17 y)
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn E: Wk 14 (>=17 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 14 (>=17 y)
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 30 (>=17 y)
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 46 (>=17 y)
|
5.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn D: Wk 46 (>=17 y)
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn E: Wk 46 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 46 (>=17 y)
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn A: Wk 62 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn B: Wk 62 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 62 (>=17 y)
|
2.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn D: Wk 62 (>=17 y)
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 62 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 78 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 94 (>=17 y)
|
2.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn E: Wk 94 (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 94 (>=17 y)
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 118 (>=17 y)
|
4.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Wk 142 (>=17 y)
|
2.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Wk 142 (>=17 y)
|
2.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: Early TV (>=17 y)
|
6.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn E: Early TV (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: Early TV (>=17 y)
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn C: TV (>=17 y)
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Abn F: TV (>=17 y)
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: Wk 0 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 0 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn E: Wk 0 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 0 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 2 (>=17 y)
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 2 (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn A: Wk 14 (>=12 y-<17 y)
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 14 (>=17 y)
|
5.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: Wk 14 (>=17 y)
|
1.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn E: Wk 14 (>=17 y)
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 14 (>=17 y)
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 30 (>=17 y)
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 30 (>=17 y)
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 46 (>=17 y)
|
7.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: Wk 46 (>=17 y)
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn E: Wk 46 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 46 (>=17 y)
|
3.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn A: Wk 62 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn B: Wk 62 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 62 (>=17 y)
|
2.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: Wk 62 (>=17 y)
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn E: Wk 62 (>=17 y)
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 62 (>=17 y)
|
3.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 78 (>=17 y)
|
5.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 78 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 94 (>=17 y)
|
5.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: Wk 94 (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn E: Wk 94 (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 94 (>=17 y)
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn A: Wk 118 (>=12 y-<17 y)
|
50.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 118 (>=17 y)
|
14.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: Wk 118 (>=17 y)
|
4.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn E: Wk 118 (>=17 y)
|
4.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 118 (>=17 y)
|
9.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn A: Wk 142 (>=12 y-<17 y)
|
9.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 142 (>=17 y)
|
8.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 142 (>=17 y)
|
4.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 166 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Wk 190 (>=17 y)
|
7.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Wk 190 (>=17 y)
|
3.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: Early TV (>=17 y)
|
6.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: Early TV (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn E: Early TV (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: Early TV (>=17 y)
|
6.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn C: TV (>=17 y)
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn D: TV (>=17 y)
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Abn F: TV (>=17 y)
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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).
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn B: Wk 2 (3 y-<12 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn D: Wk 2 (>=12 y-<17 y)
|
5.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 2 (>=17 y)
|
1.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn F: Wk 2 (>=17 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 14 (>=17 y)
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 30 (>=17 y)
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn F: Wk 30 (>=17 y)
|
0.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn C: Wk 46 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 46 (>=17 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn B: Wk 62 (3 y-<12 y)
|
20.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn C: Wk 62 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 62 (>=17 y)
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn F: Wk 62 (>=17 y)
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 78 (>=17 y)
|
5.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn F: Wk 78 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn G: Wk 78 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn B: Wk 94 (3 y-<12 y)
|
28.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn C: Wk 94 (>=12 y-<17 y)
|
7.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 94 (>=17 y)
|
2.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn F: Wk 94 (>=17 y)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn G: Wk 94 (>=17 y)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn D: Wk 118 (>=12 y-<17 y)
|
50.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Wk 142 (>=17 y)
|
8.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn F: Wk 142 (>=17 y)
|
2.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn E: Early TV (>=17 y)
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Abn F: Early TV (>=17 y)
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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).
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 118 (>=17 y)
|
14.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 2 (>=17 y)
|
5.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn D: Wk 14 (>=12 y-<17 y)
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 14 (>=17 y)
|
9.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn F: Wk 14 (>=17 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 30 (>=17 y)
|
7.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn A: Wk 46 (3 y-<12 y)
|
8.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn D: Wk 46 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 46 (>=17 y)
|
7.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn D: Wk 62 (>=12 y-<17 y)
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 62 (>=17 y)
|
10.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn F: Wk 62 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 78 (>=17 y)
|
8.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn F: Wk 78 (>=17 y)
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn C: Wk 94 (>=12 y-<17 y)
|
7.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn D: Wk 94 (>=12 y-<17 y)
|
7.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 94 (>=17 y)
|
6.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn F: Wk 94 (>=17 y)
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Wk 142 (>=17 y)
|
10.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: Early TV (>=17 y)
|
10.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn E: TV (>=17 y)
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Abn F: TV (>=17 y)
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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).
Outcome measures
| Measure |
All Participants (Lacosamide)
n=216 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn D: Wk 46 (>=12 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 62 (>=12 y)
|
3.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn D: Wk 62 (>=12 y)
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 78 (>=12 y)
|
3.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 94 (>=12 y)
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 118 (>=12 y)
|
4.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn D: Wk 214 (>=12 y)
|
100 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn D: TV (>=12 y)
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 2 (>=12 y)
|
1.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 14 (>=12 y)
|
2.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 30 (>=12 y)
|
1.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Abn C: Wk 46 (>=12 y)
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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).
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 38 (>=17 y)- Std 3 min
|
0.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 2 (>=17 y)-Sup 3 min
|
4.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 2 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High: Wk 2 (>=12 y-<17 y)-Std 1 min
|
5.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 2 (>=17 y)-Std 1 min
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 2 (>=17 y)-Std 1 min
|
3.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 2 (>=17 y)-Std 3 min
|
1.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 2 (>=17 y)-Std 3 min
|
2.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low A: Wk 6 (>=17 y)-Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 6 (>=17 y)-Sup 3 min
|
4.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 6 (>=17 y)-Sup 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High: Wk 6 (>=12 y-<17 y)- Std 1 min
|
4.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 6 (>=17 y)- Std 1 min
|
1.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 6 (>=17 y)- Std 1 min
|
3.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low A: Wk 6 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 6 (>=17 y)- Std 3 min
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 6 (>=17 y)- Std 3 min
|
2.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 14 (>=17 y)- Sup 3 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 14 (>=17 y)- Sup 3 min
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High: Wk 14 (>=12 y-<17 y)- Std 1 min
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 14 (>=17 y)- Std 1 min
|
3.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 14 (>=17 y)- Std 1 min
|
2.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 14 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 14 (>=17 y)- Std 3 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 22 (>=17 y)- Sup 3 min
|
3.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 22 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High A: Wk 22 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 22 (>=17 y)- Std 1 min
|
1.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 22 (>=17 y)- Std 1 min
|
4.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 22 (>=17 y)- Std 3 min
|
2.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 22 (>=17 y)- Std 3 min
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 30 (>=17 y)- Sup 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 30 (>=17 y)- Std 1 min
|
5.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 30 (>=17 y)- Std 1 min
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 30 (>=17 y)- Std 3 min
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 30 (>=17 y)- Std 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 38 (>=17 y)- Sup 3 min
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 38 (>=17 y)- Std 1 min
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 38 (>=17 y)- Std 1 min
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 38 (>=17 y)- Std 3 min
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 46 (>=17 y)- Sup 3 min
|
5.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 46 (>=17 y)- Sup 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low A: Wk 46 (>=17 y)- Std 1 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High A: Wk 46 (>=17 y)- Std 1 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 46 (>=17 y)- Std 1 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 46 (>=17 y)- Std 1 min
|
5.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 46 (>=17 y)- Std 3 min
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 46 (>=17 y)- Std 3 min
|
4.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 62 (>=17 y)- Sup 3 min
|
5.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 62 (>=17 y)- Sup 3 min
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low: Wk 62 (>=12 y-<17 y)- Std 1 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High A: Wk 62 (>=17 y)- Std 1 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 62 (>=17 y)- Std 1 min
|
4.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 62 (>=17 y)- Std 1 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High A: Wk 62 (>=17 y)- Std 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 62 (>=17 y)- Std 3 min
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 62 (>=17 y)- Std 3 min
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 78 (>=17 y)- Sup 3 min
|
6.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 78 (>=17 y)- Sup 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 78 (>=17 y)- Std 1 min
|
6.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 78 (>=17 y)- Std 1 min
|
6.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 78 (>=17 y)- Std 3 min
|
6.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 78 (>=17 y)- Std 3 min
|
5.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 94 (>=17 y)- Sup 3 min
|
6.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 94 (>=17 y)- Sup 3 min
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 94 (>=17 y)- Std 1 min
|
2.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 94 (>=17 y)- Std 1 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 94 (>=17 y)- Std 3 min
|
1.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 94 (>=17 y)- Std 3 min
|
2.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 118 (>=17 y)- Sup 3 min
|
2.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 118 (>=17 y)- Sup 3 min
|
2.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 118 (>=17 y)- Std 1 min
|
2.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 118 (>=17 y)- Std 1 min
|
3.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 118 (>=17 y)- Std 3 min
|
2.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 118 (>=17 y)- Std 3 min
|
4.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High A: Wk 142 (>=17 y)- Sup 3 min
|
1.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 142 (>=17 y)- Sup 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 142 (>=17 y)- Sup 3 min
|
4.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High A: Wk 142 (>=17 y)- Std 1 min
|
3.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 142 (>=17 y)- Std 1 min
|
7.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High A: Wk 142 (>=17 y)- Std 3 min
|
1.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 142 (>=17 y)- Std 3 min
|
3.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 142 (>=17 y)- Std 3 min
|
7.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 166 (>=17 y)- Sup 3 min
|
3.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 166 (>=17 y)- Sup 3 min
|
1.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 166 (>=17 y)- Std 1 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 166 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 166 (>=17 y)- Std 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Wk 190 (>=17 y)- Sup 3 min
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 190 (>=17 y)- Sup 3 min
|
8.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 190 (>=17 y)- Std 1 min
|
11.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 190 (>=17 y)- Std 3 min
|
17.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 214 (>=17 y)- Sup 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 214 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Wk 214 (>=17 y)- Std 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Early TV (>=17 y)- Sup 3 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Early TV (>=17 y)- Sup 3 min
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High: Early TV (>=12 y-<17 y)- Std 1 min
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: Early TV (>=17 y)- Std 1 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: Early TV (>=17 y)- Std 1 min
|
5.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low A: TV (>=17 years)- Sup 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: TV (>=17 years)- Sup 3 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: TV (>=17 years)- Sup 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: TV (>=17 years)- Std 1 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: TV (>=17 years)- Std 1 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Low B: TV (>=17 years)- Std 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
High B: TV (>=17 years)- Std 3 min
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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'.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 78 (>=17 y)- Sup 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Early TV (>=17 y)- Std 1 min
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 142 (>=17 y)- Std 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 166 (>=17 y)- Sup 3 min
|
3.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 166 (>=17 y)- Std 1 min
|
7.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 166 (>=17 y)- Std 3 min
|
7.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 190 (>=17 y)- Sup 3 min
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 214 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High C: Wk 214 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 214 (>=17 y)- Std 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 262 (>=17 y)- Std 3 min
|
100 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Early TV (>=17 y)- Sup 3 min
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: TV (>=17 y)- Std 1 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 2 (>=17 y)- Sup 3 min
|
3.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 2 (>=17 y)- Std 1 min
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 2 (>=17 y)- Std 1 min
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 2 (>=17 y)- Std 3 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 6 (>=17 y)- Sup 3 min
|
3.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 6 (>=17 y)- Std 1 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 6 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 6 (>=17 y)- Std 3 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 14 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 14 (>=17 y)- Sup 3 min
|
3.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 14 (>=17 y)- Std 1 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 14 (>=17 y)- Std 3 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 22 (>=17 y)- Sup 3 min
|
4.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 22 (>=17 y)- Std 1 min
|
4.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 22 (>=17 y)- Std 3 min
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 30 (>=17 y)- Sup 3 min
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 30 (>=17 y)- Sup 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 30 (>=17 y)- Std 1 min
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 30 (>=17 y)- Std 3 min
|
5.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 38 (>=17 y)- Sup 3 min
|
0.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 38 (>=17 y)- Sup 3 min
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 38 (>=17 y)- Std 1 min
|
0.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 38 (>=17 y)- Std 1 min
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 38 (>=17 y)- Std 3 min
|
3.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low: Wk 46 (>=12 y-<17 y)- Sup 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 46 (>=17 y)- Sup 3 min
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low: Wk 46 (>=12 y-<17 y)- Std 1 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 46 (>=17 y)- Std 1 min
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low: Wk 46 (>=12 y-<17 y)- Std 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 46 (>=17 y)- Std 3 min
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High C: Wk 46 (>=17 y)- Std 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 62 (>=17 y)- Sup 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 62 (>=17 y)- Sup 3 min
|
3.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low: Wk 62 (>=12 y-<17 y)- Std 1 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low A: Wk 62 (>=17 y)- Std 1 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: TV (>=17 y)- Std 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 62 (>=17 y)- Std 1 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 62 (>=17 y)- Std 1 min
|
2.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low A: Wk 62 (>=17 y)- Std 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low B: Wk 62 (>=17 y)- Std 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 62 (>=17 y)- Std 3 min
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Low A: Wk 78 (>=17 y)- Sup 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 78 (>=17 y)- Std 1 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 78 (>=17 y)- Std 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 94 (>=17 y)- Sup 3 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 94 (>=17 y)- Std 1 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 94 (>=17 y)- Std 3 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 118 (>=17 y)- Sup 3 min
|
5.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High C: Wk 118 (>=17 y)- Sup 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 118 (>=17 y)- Std 1 min
|
5.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High C: Wk 118 (>=17 y)- Std 1 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 118 (>=17 y)- Std 3 min
|
6.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High C: Wk 118 (>=17 y)- Std 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 142 (>=17 y)- Sup 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
High B: Wk 142 (>=17 y)- Std 1 min
|
6.3 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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'.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low: Wk 22 (>=12 y-<17 y)- Sup 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 22 (>=17 y)- Sup 3 min
|
1.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 22 (>=17 y)- Std 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low: Wk 2 (3 y-<12 y)- Sup 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low B: Wk 2 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 2 (>=17 y)- Sup 3 min
|
2.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low: Wk 2 (3 y-<12 y)- Std 1 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 2 (3 y-<12 y)- Std 1 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 2 (>=17 y)- Std 1 min
|
5.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 2 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low: Wk 2 (3 y-<12 y)- Std 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 2 (3 y-<12 y)- Std 3 min
|
12.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 2 (>=17 y)- Std 3 min
|
6.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 2 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 6 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 6 (>=17 y)- Sup 3 min
|
4.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 6 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 6 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 6 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 6 (>=17 y)- Std 1 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 6 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 6 (3 y-<12 y)- Std 3 min
|
7.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 6 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low B: Wk 6 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 6 (>=17 y)- Std 3 min
|
6.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 6 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 14 (3 y-<12 y)- Sup 3 min
|
7.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 14 (>=17 y)- Sup 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 14 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 14 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 14 (>=17 y)- Std 1 min
|
3.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 14 (>=17 y)- Std 1 min
|
1.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 14 (3 y-<12 y)- Std 3 min
|
8.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 14 (>=17 y)- Std 3 min
|
4.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 14 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 22 (3 y-<12 y)- Sup 3 min
|
15.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 22 (>=17 y)- Sup 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 22 (3 y-<12 y)- Std 1 min
|
15.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 22 (>=17 y)- Std 1 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low B: Wk 22 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 22 (>=17 y)- Std 1 min
|
7.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 22 (>=17 y)- Std 1 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 22 (3 y-<12 y)- Std 3 min
|
7.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 22 (>=17 y)- Std 3 min
|
0.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 22 (>=17 y)- Std 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 30 (>=17 y)- Sup 3 min
|
3.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 30 (>=17 y)- Sup 3 min
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 30 (3 y-<12 y)- Std 1 min
|
14.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 30 (>=17 y)- Std 1 min
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 30 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 30 (>=17 y)- Std 1 min
|
0.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 30 (>=17 y)- Std 3 min
|
4.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 38 (>=17 y)- Sup 3 min
|
2.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 38 (3 y-<12 y)- Std 1 min
|
20.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 38 (>=17 y)- Std 1 min
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 38 (>=17 y)- Std 1 min
|
0.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 38 (>=17 y)- Std 3 min
|
9.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 46 (>=17 y)- Sup 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 46 (>=17 y)- Sup 3 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low: Wk 46 (>=12 y-<17 y)- Std 1 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 46 (>=17 y)- Std 1 min
|
8.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 46 (>=17 y)- Std 1 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 46 (>=17 y)- Std 3 min
|
9.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 46 (>=17 y)- Std 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 62 (>=17 y)- Sup 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 62 (>=17 y)- Sup 3 min
|
5.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 62 (>=17 y)- Sup 3 min
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 62 (3 y-<12 y)- Std 1 min
|
20.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low: Wk 62 (>=12 y-<17 y)- Std 1 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 62 (>=17 y)- Std 1 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 62 (>=17 y)- Std 1 min
|
5.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 62 (>=17 y)- Std 1 min
|
1.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low B: Wk 62 (>=17 y)- Std 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 62 (>=17 y)- Std 3 min
|
5.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 62 (>=17 y)- Std 3 min
|
0.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low: Wk 78 (>=12 y-<17 y)- Sup 3 min
|
16.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 78 (>=17 y)- Sup 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 78 (>=17 y)- Std 1 min
|
3.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 78 (>=17 y)- Std 3 min
|
3.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 78 (>=17 y)- Std 3 min
|
1.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 94 (>=17 y)- Sup 3 min
|
1.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 94 (>=17 y)- Std 1 min
|
4.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: Wk 94 (3 y-<12 y)- Std 3 min
|
14.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 94 (>=17 y)- Std 3 min
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 94 (>=17 y)- Std 3 min
|
4.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 94 (>=17 y)- Std 3 min
|
0.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 118 (>=17 y)- Sup 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 118 (>=17 y)- Sup 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low B: Wk 118 (>=17 y)- Sup 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 118 (>=17 y)- Sup 3 min
|
2.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 118 (>=17 y)- Sup 3 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low A: Wk 118 (>=17 y)- Std 1 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Low B: Wk 118 (>=17 y)- Std 1 min
|
1.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 118 (>=17 y)- Std 1 min
|
4.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 118 (>=17 y)- Std 3 min
|
7.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 142 (>=17 y)- Sup 3 min
|
6.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 142 (>=17 y)- Std 1 min
|
7.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 142 (>=17 y)- Std 3 min
|
7.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 166 (>=17 y)- Sup 3 min
|
3.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 166 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 166 (>=17 y)- Std 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 166 (>=17 y)- Std 3 min
|
11.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 166 (>=17 y)- Std 3 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 190 (>=17 y)- Std 3 min
|
2.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 214 (>=17 y)- Sup 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 214 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 214 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 214 (>=17 y)- Std 1 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Wk 214 (>=17 y)- Std 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Wk 214 (>=17 y)- Std 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Wk 214 (>=17 y)- Std 3 min
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Early TV (>=17 y)- Sup 3 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Early TV (>=17 y)- Sup 3 min
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Early TV (>=17 y)- Std 1 min
|
9.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Early TV (>=17 y)- Std 1 min
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High A: Early TV (>=17 y)- Std 3 min
|
1.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: Early TV (>=17 y)- Std 3 min
|
10.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: Early TV (>=17 y)- Std 3 min
|
3.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High: TV (3 y-<12 y)- Sup 3 min
|
16.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: TV (>=17 y)- Sup 3 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: TV (>=17 y)- Std 1 min
|
2.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High B: TV (>=17 y)- Std 3 min
|
4.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
High C: TV (>=17 y)- Std 3 min
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: During the study (up to approximately 5 years)Population: 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.
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).
Outcome measures
| Measure |
All Participants (Lacosamide)
n=239 Participants
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.
|
|---|---|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 94 (1 m - <17 y)
|
13.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 190 (>=17 y)
|
26.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 14 (1 m - <17 y)
|
9.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 14 (>=17 y)
|
5.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 14 (>=17 y)
|
16.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 30 (1 m - <17 y)
|
10.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 30 (>=17 y)
|
5.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 30 (>=17 y)
|
19.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 46 (1 m - <17 y)
|
7.1 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 46 (>=17 y)
|
12.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 46 (>=17 y)
|
22.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 62 (1 m - <17 y)
|
7.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 62 (>=17 y)
|
14.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 62 (>=17 y)
|
21.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 78 (>=17 y)
|
19.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 78 (>=17 y)
|
30.2 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 94 (>=17 y)
|
16.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 94 (>=17 y)
|
30.9 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Low- Wk 118 (1 m - <17 y)
|
5.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 118 (1 m - <17 y)
|
10.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 118 (>=17 y)
|
21.6 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 118 (>=17 y)
|
33.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Low- Wk 142 (1 m - <17 y)
|
7.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 142 (1 m - <17 y)
|
7.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 142 (>=17 y)
|
19.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 142 (>=17 y)
|
32.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- Wk 166 (1 m - <17 y)
|
10.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 166 (>=17 y)
|
25.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 166 (>=17 y)
|
45.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Low- Wk 190 (1 m - <17 y)
|
16.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 190 (>=17 y)
|
50.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Low- Wk 214 (1 m - <17 y)
|
50.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 214 (>=17 y)
|
31.8 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 214 (>=17 y)
|
54.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 238 (>=17 y)
|
16.7 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 238 (>=17 y)
|
50.0 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Wk 262 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Wk 262 (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- Early TV (>=17 y)
|
26.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- Early TV (>=17 y)
|
33.3 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
High- TV (1 m - <17 y)
|
21.4 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec A- TV (>=17 y)
|
34.5 percentage of participants
|
|
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Inc/Dec B- TV (>=17 y)
|
52.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Combined Baseline until end of Treatment Period (up to approximately 5 years)Population: 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.
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.
Outcome measures
| Measure |
All Participants (Lacosamide)
n=238 Participants
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.
|
|---|---|
|
Percent Change in Primary Generalized Tonic-clonic Seizure (PGTCS) Frequency Per 28 Days From Combined Baseline
|
-88.58 percent change
Interval -100.0 to 465.4
|
Adverse Events
All Participants (Lacosamide)
Serious events: 54 serious events
Other events: 176 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
All Participants (Lacosamide)
n=239 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Cardiac disorders
Cardiac failure acute
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Eye disorders
Diplopia
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Eye disorders
Periorbital oedema
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.84%
2/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
General disorders
Death
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
General disorders
Drowning
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
General disorders
Non-cardiac chest pain
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Infected dermal cyst
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Otitis media acute
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Urinary tract infection
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.84%
2/239 • Number of events 4 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.84%
2/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.84%
2/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Epidural haemorrhage
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Investigations
Drug level increased
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Investigations
Weight decreased
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.42%
1/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Grand mal convulsion
|
6.7%
16/239 • Number of events 20 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Status epilepticus
|
1.7%
4/239 • Number of events 7 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.84%
2/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.42%
1/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Brain injury
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Convulsion
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Dizziness
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Migraine
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Psychiatric disorders
Suicide attempt
|
0.84%
2/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Psychiatric disorders
Completed suicide
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Psychiatric disorders
Mental status changes
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Psychiatric disorders
Psychogenic seizure
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.84%
2/239 • Number of events 2 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Vascular disorders
Peripheral ischaemia
|
0.42%
1/239 • Number of events 1 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
Other adverse events
| Measure |
All Participants (Lacosamide)
n=239 participants at risk
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.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
7.9%
19/239 • Number of events 30 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Eye disorders
Diplopia
|
5.0%
12/239 • Number of events 15 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Nausea
|
9.6%
23/239 • Number of events 31 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
18/239 • Number of events 23 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
16/239 • Number of events 24 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
General disorders
Fatigue
|
5.4%
13/239 • Number of events 15 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
General disorders
Pyrexia
|
5.4%
13/239 • Number of events 13 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Nasopharyngitis
|
21.8%
52/239 • Number of events 91 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Influenza
|
7.5%
18/239 • Number of events 23 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
17/239 • Number of events 18 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Infections and infestations
Corona virus infection
|
5.9%
14/239 • Number of events 16 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
24/239 • Number of events 30 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
12/239 • Number of events 14 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
17/239 • Number of events 19 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Headache
|
23.4%
56/239 • Number of events 113 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Dizziness
|
22.2%
53/239 • Number of events 73 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Somnolence
|
16.7%
40/239 • Number of events 51 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Grand mal convulsion
|
5.9%
14/239 • Number of events 16 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
|
|
Nervous system disorders
Migraine
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5.4%
13/239 • Number of events 17 • From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60