A Study of Brivaracetam in Subjects With Partial Onset Seizures

Phase 2

Completed

• Conditions: Epilepsy, Focal
• Interventions: Other: Placebo; Drug: Brivaracetam

• Registration Number: NCT00175929
• Lead Sponsor: UCB Pharma

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
• Subjects with a history of partial onset seizures
• Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
• Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
• Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted

Exclusion Criteria

• Seizure type IA non-motor as only seizure type
• History or presence of seizures occurring only in clustered patterns
• History of cerebrovascular accident (CVA)
• Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tablets administered twice a day
Brivaracetam 50 mg/day	Brivaracetam	Brivaracetam 50 mg/day, 25 mg administered twice a day
Brivaracetam 150 mg/day	Brivaracetam	Brivaracetam 150 mg/day, 75 mg administered twice a day

Primary Outcome Measures

Name	Time	Method
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period	7-week maintenance period	Partial onset seizure frequency (Type I) per week over the 7-week maintenance period

Secondary Outcome Measures

Name	Time	Method
Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period	During the Maintenance period (approximately 7 weeks)
Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period	During the Maintenance period (approximately 7 weeks)	The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance period was grouped in 5 categories: \< -25%, -25% to \< 25%, 25% to \< 75%, 75% to ≤ 100%, and 100%.
Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period	During the Maintenance period (approximately 7 weeks)
Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period	During the Maintenance period (approximately 7 weeks)
Responder rate in partial onset seizures (type I) over the 7-week Maintenance period	During the Maintenance period (approximately 7 weeks)	A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.
Percentage of seizure-free subjects over the 7-week Maintenance period	During the Maintenance period (approximately 7 weeks)
Time to N-th seizure in the Maintenance period	During the Maintenance period (approximately 7 weeks)
Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods	Baseline through Maintenance period (approximately 11 weeks)