NCT00490035

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

A Multi-center, 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: 399 (actual)
• Sponsor: UCB Pharma SA · 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	Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period
DRUG	Brivaracetam	Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period
DRUG	Brivaracetam	Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.
DRUG	Brivaracetam	Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-06-22
• Last updated: 2022-07-21
• Results posted: 2016-04-13

Locations

76 sites across 12 countries: Belgium, Finland, France, Germany, Hungary, India, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom