NCT00357669

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

A Multi-center, 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: 50 (actual)
• Sponsor: UCB Pharma SA · 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.

Conditions

• Unverricht-Lundborg Disease

Interventions

Type	Name	Description
DRUG	Brivaracetam 25 mg	* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 25 mg * Route of Administration: Oral use
DRUG	Brivaracetam 50 mg	* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 50 mg * Route of Administration: Oral use
OTHER	Placebo	* Active Substance: Placebo Pharmaceutical Form: Tablet * Concentration: 25 mg and 50 mg * Route of Administration: Oral use

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-07-27
• Last updated: 2015-05-18

Locations

13 sites across 7 countries: Finland, France, Italy, Netherlands, Reunion, Sweden, Tunisia