Trial Outcomes & Findings for A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment (NCT NCT04627285)
NCT ID: NCT04627285
Last Updated: 2025-08-28
Results Overview
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Results posted on
2025-08-28
Participant Flow
The study started to enroll participants in December 2020 and concluded in February 2025.
Participants who completed studies EP0034 (NCT01964560) or SP848 (NCT00938912) were offered participation in this study. The Participant Flow refers to the Safety Set (SS).
Participant milestones
| Measure |
Lacosamide: >=2 to <4 Years
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
29
|
|
Overall Study
COMPLETED
|
12
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Lacosamide: >=2 to <4 Years
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Sponsor decision
|
5
|
0
|
|
Overall Study
Participant left country; aunt informed the site
|
0
|
1
|
Baseline Characteristics
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
Baseline characteristics by cohort
| Measure |
Lacosamide: >=2 to <4 Years
n=19 Participants
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 Participants
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.888 years
STANDARD_DEVIATION 0.518 • n=5 Participants
|
5.180 years
STANDARD_DEVIATION 0.642 • n=7 Participants
|
4.273 years
STANDARD_DEVIATION 1.277 • n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 24 months to less than (<) 12 years
|
19 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)Population: The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study.
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
Outcome measures
| Measure |
Lacosamide: >=2 to <4 Years
n=19 Participants
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 Participants
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
|
42.1 percentage of participants
|
37.9 percentage of participants
|
PRIMARY outcome
Timeframe: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)Population: The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.
Outcome measures
| Measure |
Lacosamide: >=2 to <4 Years
n=19 Participants
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 Participants
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Percentage of Participants Who Withdrew From Study Due to TEAEs
|
0.0 percentage of participants
|
6.9 percentage of participants
|
PRIMARY outcome
Timeframe: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)Population: The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study.
A SAE is defined as results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect, other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. Only participants who discontinued the study due to SAEs are reported.
Outcome measures
| Measure |
Lacosamide: >=2 to <4 Years
n=19 Participants
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 Participants
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Percentage of Participants Who Withdrew From Study Due to Serious Adverse Event (SAEs)
|
0.0 percentage of participants
|
6.9 percentage of participants
|
PRIMARY outcome
Timeframe: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)Population: The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study.
The modal daily LCM dose in milligram per kilogram (mg/kg/day) is defined as the daily Lacosamide dose the participant received for the longest duration in EP0151.
Outcome measures
| Measure |
Lacosamide: >=2 to <4 Years
n=19 Participants
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 Participants
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Modal Daily Dose During the Study
|
9.5 mg/kg/day
Standard Deviation 2.4
|
10.0 mg/kg/day
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)Population: The SS consisted of all study participants who signed an ICF and took at least 1 dose of study medication in this study.
Maximum daily dose is defined as the highest total daily dose a participant received in EP0151.
Outcome measures
| Measure |
Lacosamide: >=2 to <4 Years
n=19 Participants
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 Participants
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Maximum Daily Dose During the Study
|
9.5 mg/kg/day
Standard Deviation 2.4
|
10.1 mg/kg/day
Standard Deviation 2.6
|
Adverse Events
Lacosamide: >=2 to <4 Years
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Lacosamide: >=4 to <6 Years
Serious events: 5 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lacosamide: >=2 to <4 Years
n=19 participants at risk
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 participants at risk
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
General disorders
Device malfunction
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 7 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Infections and infestations
Bronchopneumonia
|
5.3%
1/19 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
0.00%
0/29 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
0.00%
0/29 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
5.3%
1/19 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
0.00%
0/29 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
5.3%
1/19 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
0.00%
0/29 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 2 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/19 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
3.4%
1/29 • Number of events 1 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
Other adverse events
| Measure |
Lacosamide: >=2 to <4 Years
n=19 participants at risk
Participants aged greater than or equal to (\>=) 2 to less than (\<) 4 years when entering EP0151 received LCM oral solution twice per day (BID) from a minimum dose of 2 milligram per kilogram per day (mg/kg/day) to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
Lacosamide: >=4 to <6 Years
n=29 participants at risk
Participants aged \>=4 to \<6 years when entering EP0151 received LCM oral solution BID from a minimum dose of 2 mg/kg/day to a maximum dose of 12 mg/kg/day or 600 mg/day, to whichever was lower up to 209 weeks, based on optimization of seizure control and tolerability in the judgement of the Investigator.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
26.3%
5/19 • Number of events 15 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
13.8%
4/29 • Number of events 7 • From visit 1 (Week 0) to the end of study visit (up to Week 214.42)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent. Safety set included all participants who signed an ICF and took at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60