NCT00464269

Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	Placebo	* Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg, 10 mg and 25 mg * Route of Administration: Oral use
DRUG	Brivaracetam 2.5 mg	* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg * Route of Administration: Oral use
DRUG	Brivaracetam 10 mg	* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 10 mg * Route of Administration: Oral use
DRUG	Brivaracetam 25 mg	* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 25 mg * Route of Administration: Oral use

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2007-04-23
• Last updated: 2022-07-21
• Results posted: 2016-04-13

Locations

69 sites across 5 countries: United States, Australia, Brazil, Canada, Mexico