At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 480 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Brivaracetam 20 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.
An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
In Brief
A Phase 3 clinical trial evaluating Placebo and Brivaracetam for Epilepsy. Completed, enrolled 480 participants across 61 sites in 15 countries.
Detailed Summary
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustria, Belgium, Czechia, Germany, Hong Kong, India, Italy, Norway, Russia, Singapore, South Africa, South Korea, Sweden, Taiwan, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2007
Enrollment StartOct 2007
Primary CompletionNov 2008
Study CompletionDec 2008
TodayJul 2026
First PostedJul 20, 2007
Enrollment StartOct 1, 2007
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.9 years ago
Interventions
Placebodrug
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period
Brivaracetamdrug
Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period