CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 56 enrolled
Drug / intervention
BRV 2.5 mg +3 moredrug
Likely dose
BRV 2.5 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/NCT00368251
NCT00368251Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥ 16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

UCB Pharma·interventional·Posted Aug 24, 2006·Updated May 31, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo, BRV 2.5 mg, and 2 other interventions for Unverricht-Lundborg Disease. Completed, enrolled 56 participants across 18 sites in 8 countries.

Detailed Summary

The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnverricht-Lundborg Disease
CountriesCanada, Finland, France, Israel, Russia, Serbia, Tunisia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2006
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.9 years ago

Interventions

Placeboother

* Pharmaceutical Form: Tablet * Concentration: 2.5 mg, 25 mg and 50 mg * Route of Administration: Oral use

BRV 2.5 mgdrug

* Pharmaceutical Form: Tablet * Concentration: 2.5 mg * Route of Administration: Oral use

BRV 25 mgdrug

* Pharmaceutical Form: Tablet * Concentration: 25 mg * Route of Administration: Oral use

BRV 50 mgdrug

* Pharmaceutical Form: Tablet * Concentration: 50 mg * Route of Administration: Oral use