A Study of Brivaracetam in Subjects With Partial Onset Seizures

UCB Pharma157 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

157

Conditions

Epilepsy, Focal

Interventions

PlaceboOTHER

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)

BrivaracetamDRUG

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)

BrivaracetamDRUG

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)

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (56)

Outcomes

Primary Outcomes

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

Time frame: 7-week maintenance period