Trials / Completed
CompletedNCT01339559
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 767 (actual)
- Sponsor
- UCB BIOSCIENCES, Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
Detailed description
The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brivaracetam | 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. |
Timeline
- Start date
- 2011-05-11
- Primary completion
- 2019-04-18
- Completion
- 2019-04-18
- First posted
- 2011-04-20
- Last updated
- 2021-08-17
- Results posted
- 2020-06-04
Locations
184 sites across 28 countries: United States, Austria, 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
Source: ClinicalTrials.gov record NCT01339559. Inclusion in this directory is not an endorsement.