NCT00175929

A Study of Brivaracetam in Subjects With Partial Onset Seizures

A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy

Conditions

• Epilepsy, Focal

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 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance 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 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
DRUG	Brivaracetam	Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-09-15
• Last updated: 2015-04-13

Locations

56 sites across 9 countries: Belgium, Czechia, Finland, France, Germany, Netherlands, Poland, Spain, United Kingdom