Actively Recruiting
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Led by UCB Biopharma SRL · Updated on 2025-06-27
70
Participants Needed
36
Research Sites
486 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
CONDITIONS
Official 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...
- Participants at least 1 month old with confirmed epilepsy who participated in prior related studies N01266 and/or N01349
- For participants enrolling directly in Japan: aged 4 to under 16 years
- For participants enrolling directly in Japan: EEG compatible with focal epilepsy within the last 10 years
- For participants enrolling directly in Japan: uncontrolled partial-onset seizures after treatment with at least one antiepileptic drug
- For participants enrolling directly in Japan: at least one partial-onset seizure during the 4-week screening period
You will not qualify if you...
- Severe medical, neurological, or psychiatric disorders or abnormal lab values that may affect safety
- Currently participating in another investigational drug or device study other than brivaracetam
- For long-term follow-up participants aged 6 or older: history of suicide attempt or suicidal ideation in past 6 months
- For direct enrollment in Japan: history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
- For direct enrollment in Japan: history of status epilepticus within 30 days before screening or during screening period
- For direct enrollment in Japan: any clinically significant illness or laboratory abnormality
- For direct enrollment in Japan: clinically significant ECG abnormality
- For direct enrollment in Japan: major surgery within 6 months prior to screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Withdrawn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Withdrawn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Withdrawn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Withdrawn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
CONTACT
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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