CompletedPhase 3

A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

United States84 participantsStarted 2022-03-30

Plain-language summary

The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Who can participate

Age range2 Years – 26 Years

SexALL

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Inclusion criteria

✓. The study participant is premenarchal OR
✓. A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment

What they're measuring

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months

Percentage of Participants With TEAEs Leading to Discontinuation of Study Treatment

Timeframe: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months

Trial details

NCT IDNCT05109234

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-18

Results submitted2025-09-17

View on ClinicalTrials.gov More Childhood Absence Epilepsy trials