NCT00699283

A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam	25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
DRUG	Brivaracetam	25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-06-17
• Last updated: 2018-07-11
• Results posted: 2017-01-18

Locations

68 sites across 6 countries: United States, France, Germany, Hungary, Italy, Spain