NCT00368251

Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Unverricht-Lundborg Disease

Interventions

Type	Name	Description
OTHER	Placebo	* Pharmaceutical Form: Tablet * Concentration: 2.5 mg, 25 mg and 50 mg * Route of Administration: Oral use
DRUG	BRV 2.5 mg	* Pharmaceutical Form: Tablet * Concentration: 2.5 mg * Route of Administration: Oral use
DRUG	BRV 25 mg	* Pharmaceutical Form: Tablet * Concentration: 25 mg * Route of Administration: Oral use
DRUG	BRV 50 mg	* Pharmaceutical Form: Tablet * Concentration: 50 mg * Route of Administration: Oral use

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-08-24
• Last updated: 2023-05-31
• Results posted: 2016-04-13

Locations

18 sites across 8 countries: United States, Canada, Finland, France, Israel, Russia, Serbia, Tunisia