Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures. (NCT NCT01969851)
NCT ID: NCT01969851
Last Updated: 2019-05-07
Results Overview
The mean change in the count of generalized spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
From Baseline (Day 1) to Visit 6 (Week 6)
Results posted on
2019-05-07
Participant Flow
The study started to enroll patients in February 2014 and concluded in April 2018.
The Participant Flow refers to the Safety Set which consisted of all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Participant milestones
| Measure |
Lacosamide 1 Month - <4 Years
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <12 Years
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
24
|
21
|
|
Overall Study
COMPLETED
|
9
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
7
|
Reasons for withdrawal
| Measure |
Lacosamide 1 Month - <4 Years
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <12 Years
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
No effective dose in Titration period
|
0
|
0
|
1
|
|
Overall Study
Sponsor decision
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.
Baseline characteristics by cohort
| Measure |
Lacosamide 1 Month - <4 Years
n=10 Participants
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <12 Years
n=24 Participants
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years
n=21 Participants
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Total Title
n=55 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
2.716 years
STANDARD_DEVIATION 0.765 • n=5 Participants
|
6.969 years
STANDARD_DEVIATION 1.998 • n=7 Participants
|
14.753 years
STANDARD_DEVIATION 1.766 • n=5 Participants
|
9.168 years
STANDARD_DEVIATION 4.994 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to Visit 6 (Week 6)Population: The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
The mean change in the count of generalized spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
Outcome measures
| Measure |
Lacosamide 1 Month - <4 Years SS
n=9 Participants
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <2 Years SS
n=22 Participants
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years SS
n=14 Participants
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Mean Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 to Visit 6
|
-4.55 discharges
Standard Deviation 257.32
|
-166.22 discharges
Standard Deviation 447.80
|
-203.12 discharges
Standard Deviation 432.42
|
PRIMARY outcome
Timeframe: Baseline Period to the Maintenance Period (approximately 24 weeks)Population: The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
The mean change in the count of days with generalized seizures was presented.
Outcome measures
| Measure |
Lacosamide 1 Month - <4 Years SS
n=10 Participants
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <2 Years SS
n=23 Participants
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years SS
n=20 Participants
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Mean Change in Days With Any Generalized Seizures (Absence, Myoclonic, Clonic, Tonic, Tonic-clonic, Atonic, Partial Evolving to Secondarily Generalized) Per 28 Days From the Baseline Period to the Maintenance Period (Approximately 24 Weeks)
|
0.50 days
Standard Deviation 6.63
|
-1.90 days
Standard Deviation 3.76
|
-3.38 days
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Visit 6 (Week 6)Population: The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
The mean change in the count of 3 Hertz (Hz) spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
Outcome measures
| Measure |
Lacosamide 1 Month - <4 Years SS
n=9 Participants
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <2 Years SS
n=22 Participants
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years SS
n=14 Participants
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Mean Changes in Count of 3 Hz Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory EEG From Visit 2 to Visit 6
|
-0.14 count of discharges
Standard Deviation 0.42
|
-1.60 count of discharges
Standard Deviation 9.92
|
0.00 count of discharges
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: From Baseline to End of Study (approximately 32 weeks)Population: The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Lacosamide 1 Month - <4 Years SS
n=10 Participants
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <2 Years SS
n=24 Participants
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years SS
n=21 Participants
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Number of Subject Withdrawals Due to Adverse Events From Baseline to End of Study (Approximately 32 Weeks)
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Baseline to End of Study (approximately 32 weeks)Population: The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Lacosamide 1 Month - <4 Years SS
n=10 Participants
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <2 Years SS
n=24 Participants
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years SS
n=21 Participants
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Number of Subjects Experiencing at Least 1 Treatment-emergent Adverse Event From Baseline to End of Study (Approximately 32 Weeks)
|
10 Participants
|
21 Participants
|
18 Participants
|
Adverse Events
Lacosamide 1 Month - <4 Years
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Lacosamide 4 Years - <12 Years
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Lacosamide 12 Years - <18 Years
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide 1 Month - <4 Years
n=10 participants at risk
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <12 Years
n=24 participants at risk
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years
n=21 participants at risk
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
0.00%
0/24 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
Other adverse events
| Measure |
Lacosamide 1 Month - <4 Years
n=10 participants at risk
Subjects, aged 1 month to \<4 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50 kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 4 Years - <12 Years
n=24 participants at risk
Subjects, aged 4 years to \<12 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
Lacosamide 12 Years - <18 Years
n=21 participants at risk
Subjects, aged 12 years to \<18 years, who were administered Lacosamide oral solution (for subjects weighing \<50 kg) or tablet (for subjects weighing \>=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing \<50 kg), or 100 mg/day (for subjects weighing \>=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing \<50kg, or 200 mg/day for subjects weighing \>=50 kg; not to exceed 12 mg/kg/day for subjects weighing \<50 kg, or 600 mg/day in subjects weighing \>=50 kg.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
16.7%
4/24 • Number of events 5 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
0.00%
0/24 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
General disorders
Pyrexia
|
40.0%
4/10 • Number of events 5 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
25.0%
6/24 • Number of events 7 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
14.3%
3/21 • Number of events 3 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
General disorders
Irritability
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
5/10 • Number of events 7 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
14.3%
3/21 • Number of events 3 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Pharyngotonsillitis
|
20.0%
2/10 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.2%
1/24 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
14.3%
3/21 • Number of events 3 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
16.7%
4/24 • Number of events 4 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 3 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
12.5%
3/24 • Number of events 3 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Ear infection
|
10.0%
1/10 • Number of events 3 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
0.00%
0/24 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Somnolence
|
40.0%
4/10 • Number of events 4 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 3 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 6 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
0.00%
0/24 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
19.0%
4/21 • Number of events 7 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/10 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
16.7%
4/24 • Number of events 4 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • Adverse events were collected throughout the study (up to week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60