NCT00761774

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used 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: 108 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam	Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.

Timeline

• Start date: 2008-11-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2008-09-30
• Last updated: 2018-07-11
• Results posted: 2018-04-23

Locations

58 sites across 11 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Spain, Sweden