CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 768 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Brivaracetam 100 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.

Search/NCT01261325
NCT01261325Phase 3Completed
CompareCT.gov

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

UCB Pharma·interventional·Posted Dec 16, 2010·Updated Jul 22, 2022

In Brief

A Phase 3 clinical trial evaluating Placebo, Brivaracetam, and 1 other intervention for Epilepsy. Completed, enrolled 768 participants across 207 sites in 28 countries.

Detailed 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.

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 PostedDec 16, 2010
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.5 years ago

Interventions

Placebodrug

Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period

Brivaracetamdrug

Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period

Brivaracetamdrug

Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.

Antiepileptic drugs with market authorization available per countrydrug