CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 257 enrolled
Drug / intervention
Brivaracetam (BRV)drug
Likely dose
Brivaracetam (BRV) 5.0 mg/kgfrom 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/NCT01364597
NCT01364597Phase 3Completed
CompareCT.gov

Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

UCB Pharma SA·interventional·Posted Jun 2, 2011·Updated Oct 20, 2025

In Brief

A Phase 3 clinical trial evaluating Brivaracetam (BRV) for Epilepsy. Completed, enrolled 257 participants across 56 sites in 12 countries.

Detailed Summary

This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Czechia, France, Germany, Hungary, Ireland, Italy, Mexico, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2011
Enrollment StartAug 1, 2011
Primary CompletionFeb 3, 2022
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 15.1 years ago

Interventions

Brivaracetam (BRV)drug

The max BRV dose will be 5.0 mg/kg/day, not to exceed a dose of 200 mg/day for subjects with body weight \>40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights \>50kg) is reached.