Actively Recruiting

Phase 3
Age: 1Month +
All Genders
NCT04715646

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

Age: 1Month +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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