A Study of Brivaracetam in Subjects With Partial Onset Seizures

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Epilepsy, Focal

Intervention / Treatment
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* Other: Placebo
* Drug: Brivaracetam
* Drug: Brivaracetam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching placebo tablets administered twice a day | Other: Placebo<br>* 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)<br>|
| Experimental: Brivaracetam 50 mg/day<br>Brivaracetam 50 mg/day, 25 mg administered twice a day | Drug: Brivaracetam<br>* 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)<br>|
| Experimental: Brivaracetam 150 mg/day<br>Brivaracetam 150 mg/day, 75 mg administered twice a day | Drug: Brivaracetam<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial onset seizure frequency (Type I) per week over the 7-week maintenance period | Partial onset seizure frequency (Type I) per week over the 7-week maintenance period | 7-week maintenance period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| Responder rate in partial onset seizures (type I) over the 7-week Maintenance period | A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period. | During the Maintenance period (approximately 7 weeks) | 
| Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period | 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%. | During the Maintenance period (approximately 7 weeks) | 
| Percentage of seizure-free subjects over the 7-week 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) | 
| Time to N-th seizure in the Maintenance period |  | During the Maintenance period (approximately 7 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Focal Epilepsy, Partial Onset Seizures, Brivaracetam