At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 767 enrolled
Drug / intervention
Brivaracetamdrug
Likely dose
Brivaracetam 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
In Brief
A Phase 3 clinical trial evaluating Brivaracetam for Epilepsy. Completed, enrolled 767 participants across 184 sites in 28 countries.
Detailed Summary
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustria, Belgium, Brazil, Bulgaria, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Puerto Rico, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartMay 2011
Primary CompletionApr 2019
TodayJul 2026
First PostedApr 20, 2011
Enrollment StartMay 11, 2011
Primary CompletionApr 18, 2019
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 15.2 years ago
Interventions
Brivaracetamdrug
Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.