This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
768
Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.
Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Primary endpoint: United States of America (FDA)
Time frame: 12 week Treatment Period
50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.
Time frame: Baseline to 12 week Treatment Period
Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period
Time frame: Baseline to 12 week Treatment Period
Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period
Time frame: Baseline to 12 week Treatment Period
Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period
Time frame: 12 week Treatment Period
All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period
Time frame: 12 week Treatment Period
Time to the First Type I Seizure During the Treatment Period
Time frame: 12 week Treatment Period
Time to the Fifth Type I Seizure During the Treatment Period
Time frame: 12 week Treatment Period
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001
Phoenix, Arizona, United States
013
Phoenix, Arizona, United States
006
Tucson, Arizona, United States
775
Little Rock, Arkansas, United States
045
Sacramento, California, United States
025
San Francisco, California, United States
060
Aurora, Colorado, United States
085
Colorado Springs, Colorado, United States
071
Miami, Florida, United States
110
Miami, Florida, United States
...and 197 more locations
Time to the Tenth Type I Seizure During the Treatment Period
Time frame: 12 week Treatment Period