Actively Recruiting
Open-Label Study Evaluating Long-Term Safety and Tolerability of Brivaracetam as Additional Treatment in Children and Adolescents With Epilepsy
Led by UCB Biopharma SRL · Updated on 2025-06-27
70
Participants Needed
36
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and tolerability of brivaracetam in children and adolescents with epilepsy. This study includes pediatric participants who previously took part in related neonatal or long-term follow-up studies, as well as newly enrolled Japanese children with partial-onset seizures. The research also looks at pharmacokinetics in Japanese participants to better understand how the drug behaves in the body. Brivaracetam is given as tablets or oral solution twice daily in divided doses. Dosages vary based on body weight, with long-term follow-up participants receiving up to 5 mg/kg/day or 4 mg/kg/day depending on weight, not exceeding 200 mg per day. Directly enrolled Japanese participants receive 1 mg/kg/day to 4 mg/kg/day, also up to 200 mg daily. The study is open-label and single-arm, meaning all participants receive brivaracetam. Participants will be monitored for treatment-emergent adverse events, serious adverse events, and any side effects leading to stopping the medication over a period of up to 5 years. Safety visits and evaluations occur throughout this time to assess how well participants tolerate the drug long term. This helps researchers understand the ongoing effects and risks of brivaracetam when used as an add-on treatment in pediatric epilepsy.
CONDITIONS
Brief Title
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For long-term follow-up participants: at least 1 month old with confirmed epilepsy diagnosis and prior participation in related studies
- For directly enrolled participants in Japan: between 4 and under 16 years old
- For directly enrolled participants in Japan: EEG reading compatible with focal epilepsy within the last 10 years
- For directly enrolled participants in Japan: uncontrolled partial-onset seizures after adequate treatment with at least 1 antiepileptic drug
- For directly enrolled participants in Japan: at least 1 partial-onset seizure during the 4-week screening period
You will not qualify if you...
- Severe medical, neurological, or psychiatric disorders or lab values that could affect safety
- Current participation in another investigational medication or device study other than brivaracetam
- For long-term follow-up participants aged 6 or older: lifetime history of suicide attempt or suicidal ideation in past 6 months
- For directly enrolled participants in Japan: history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
- For directly enrolled participants in Japan: history of status epilepticus in the 30 days before screening or during screening
- For directly enrolled participants in Japan: any clinically significant illness
- For directly enrolled participants in Japan: clinically significant lab abnormalities increasing risk or interfering with results
- For directly enrolled participants in Japan: clinically significant ECG abnormalities
- For directly enrolled participants in Japan: major surgery within 6 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive Brivaracetam tablets or oral solution twice daily as an additional treatment for epilepsy to assess long-term safety and tolerability.
Regular visits during treatment period
Trial Site Locations
Total: 36 locations
1
Ep0156 259
Hawthorne, New York, United States, 10532
Completed
2
Ep0156 237
Durham, North Carolina, United States, 27710
Completed
3
Ep0156 204
Leuven, Belgium
Withdrawn
4
Ep0156 240
Prague, Czechia
Withdrawn
5
Ep0156 207
Loos, France
Withdrawn
6
Ep0156 209
Freiburg im Breisgau, Germany
Withdrawn
7
Ep0156 210
Budapest, Hungary
Completed
8
Ep0156 247
Budapest, Hungary
Completed
9
Ep0156 232
Miskolc, Hungary
Completed
10
Ep0156 230
Roma, Italy
Completed
11
Ep0156 803
Bunkyō City, Japan
Active, Not Recruiting
12
Ep0156 808
Chūō, Japan
Active, Not Recruiting
13
Ep0156 800
Gifu, Japan
Active, Not Recruiting
14
Ep0156 807
Hiroshima, Japan
Active, Not Recruiting
15
Ep0156 815
Kodaira-shi, Japan
Actively Recruiting
16
Ep0156 813
Kōshi, Japan
Active, Not Recruiting
17
Ep0156 806
Kyoto, Japan
Active, Not Recruiting
18
Ep0156 811
Nagoya, Japan
Active, Not Recruiting
19
Ep0156 812
Niigata, Japan
Active, Not Recruiting
20
Ep0156 817
Osaka, Japan
Actively Recruiting
21
Ep0156 818
Ōbu, Japan
Actively Recruiting
22
Ep0156 819
Ōmura, Japan
Actively Recruiting
23
Ep0156 805
Sapporo, Japan
Active, Not Recruiting
24
Ep0156 816
Sendai, Japan
Actively Recruiting
25
Ep0156 809
Shimotsuke, Japan
Active, Not Recruiting
26
Ep0156 814
Shizuoka, Japan
Actively Recruiting
27
Ep0156 804
Tokyo, Japan
Active, Not Recruiting
28
Ep0156 810
Yokohama, Japan
Active, Not Recruiting
29
Ep0156 802
Yonago, Japan
Completed
30
Ep0156 223
Aguascalientes, Mexico
Completed
31
Ep0156 609
Culiacán, Mexico
Completed
32
Ep0156 603
Guadalajara, Mexico
Completed
33
Ep0156 406
Kielce, Poland
Completed
34
Ep0156 402
Krakow, Poland
Completed
35
Ep0156 401
Poznan, Poland
Completed
36
Ep0156 248
Seville, Spain
Completed
Research Team
U
UCB Cares
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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