At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 26 enrolled
Drug / intervention
Brivaracetamdrug
Likely dose
Not stated in 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 Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy Phase 3b
In Brief
A Phase 3 clinical trial evaluating Brivaracetam for Epilepsy. Completed, enrolled 26 participants across 10 sites in 4 countries.
Detailed Summary
N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesFrance, Germany, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionAug 2016
TodayJul 2026
First PostedNov 16, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.6 years ago
Interventions
Brivaracetamdrug
Flexible dosing, can up and down-titrate as needed.