CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Brivaracetamdrug
Likely dose
Brivaracetam 0.4 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/NCT00422422
NCT00422422Phase 2Completed
CompareCT.gov

Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy

UCB Pharma·interventional·Posted Jan 17, 2007·Updated Jul 11, 2018

In Brief

A Phase 2 clinical trial evaluating Brivaracetam for Epilepsy. Completed, enrolled 100 participants across 39 sites in 6 countries.

Detailed Summary

Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Czechia, Mexico, Poland, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartJul 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.5 years ago

Interventions

Brivaracetamdrug

Oral solution Evaluation period (3 weeks up-titration): For subjects ≥8 years: * \~0.4 mg/kg bid for Week 1 * \~0.8 mg/kg bid for Week 2 * \~1.6 mg/kg bid for Week 3 For subjects \<8 years: * \~0.5 mg/kg bid for Week 1 * \~1.0 mg/kg bid for Week 2 * \~2.0 mg/kg bid for Week 3 Down-titration period (up to 2 weeks): For subjects ≥8 years: * \~0.8 mg/kg bid for Week 4 * \~0.4 mg/kg bid for Week 5 For subjects \<8 years: * \~1.0 mg/kg bid for Week 4 * \~0.5 mg/kg bid for Week 5