CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 400 enrolled
Drug / intervention
Brivaracetam 2.5 mg +3 moredrug
Likely dose
Brivaracetam 2.5 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/NCT00464269
NCT00464269Phase 3Completed
CompareCT.gov

An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures

UCB Pharma·interventional·Posted Apr 23, 2007·Updated Jul 21, 2022

In Brief

A Phase 3 clinical trial evaluating Placebo, Brivaracetam 2.5 mg, and 2 other interventions for Epilepsy. Completed, enrolled 400 participants across 69 sites in 5 countries.

Detailed Summary

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Brazil, Canada, Mexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 23, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.2 years ago

Interventions

Placeboother

* Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg, 10 mg and 25 mg * Route of Administration: Oral use

Brivaracetam 2.5 mgdrug

* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg * Route of Administration: Oral use

Brivaracetam 10 mgdrug

* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 10 mg * Route of Administration: Oral use

Brivaracetam 25 mgdrug

* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 25 mg * Route of Administration: Oral use