CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 108 enrolled
Drug / intervention
Brivaracetamdrug
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/NCT00761774
NCT00761774Phase 3Completed
CompareCT.gov

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.

UCB Pharma·interventional·Posted Sep 30, 2008·Updated Jul 11, 2018

In Brief

A Phase 3 clinical trial evaluating Brivaracetam for Epilepsy. Completed, enrolled 108 participants across 58 sites in 11 countries.

Detailed Summary

The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2008
Enrollment StartNov 1, 2008
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 17.8 years ago

Interventions

Brivaracetamdrug

Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.