NCT01261325

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 768 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Placebo	Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
DRUG	Brivaracetam	Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
DRUG	Brivaracetam	Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.
DRUG	Antiepileptic drugs with market authorization available per country

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-12-16
• Last updated: 2022-07-22
• Results posted: 2016-08-15

Locations

207 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