CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 210 enrolled
Drug / intervention
Brivaracetam +1 moredrug
Likely dose
Brivaracetam 5, 20, or 50 mg/day in two divided doses (oral tablets of 2.5 or 10 mg)AI-extracted
Key inclusion· 5
  • ✓Age 16 to 65 years
  • ✓Well-characterized focal epilepsy or epileptic syndrome per ILAE classification
  • ✓History of partial onset seizures
  • ✓At least 4 partial onset seizures during 4-week Baseline Period AND at least 2 partial onset seizures in 3 months prior to Visit 1
Key exclusion· 5
  • ✕Seizure type IA non-motor as the only seizure type
  • ✕Seizures occurring only in clusters
  • ✕Status epilepticus during the 2 years before Visit 1
  • ✕History of cerebrovascular accident (CVA)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00175825
NCT00175825Phase 2Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

UCB Pharma·interventional·Posted Sep 15, 2005·Updated Oct 2, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo and Brivaracetam for Epilepsy. Completed, enrolled 210 participants across 42 sites in 4 countries.

Detailed Summary

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBrazil, India, Mexico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartNov 7, 2005
Primary CompletionJun 29, 2006
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 20.8 years ago

Interventions

Placeboother

Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period

Brivaracetamdrug

Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period