NCT00175916

Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 853 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam (ucb 34714)	10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry 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; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.

Timeline

• Start date: 2005-09-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2005-09-15
• Last updated: 2021-08-17
• Results posted: 2020-07-16

Locations

153 sites across 26 countries: United States, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Norway, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tunisia, Ukraine