At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Brivaracetamdrug
Likely dose
Brivaracetam 10 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.
A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy
In Brief
A Phase 2 clinical trial evaluating Brivaracetam for Epilepsy. Completed, enrolled 50 participants across 17 sites in 7 countries.
Detailed Summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects \>= 1 month to \< 16 years of age with epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesCzechia, Germany, Hungary, Italy, Mexico, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartJun 2018
Primary CompletionNov 2020
TodayJul 2026
First PostedJan 23, 2018
Enrollment StartJun 1, 2018
Primary CompletionNov 4, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.4 years ago
Interventions
Brivaracetamdrug
* Pharmaceutical form: Solution for iv injection * Route of administration: intravenous use * Concentration: 10 mg/ml