This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 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
210
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
Calculated as 7-day partial onset seizure frequency.
Time frame: During the 7-week Treatment Period
Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time frame: Baseline, during the 7-week Treatment Period
Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
Time frame: During the 7-week Treatment Period
Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time frame: During the 7-week Treatment Period
Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
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Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Fresno, California, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Paducah, Kentucky, United States
Unnamed facility
Ruston, Louisiana, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
Burlington, Massachusetts, United States
...and 32 more locations
Time frame: During the 7-week Treatment Period
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time frame: During the 7-week Treatment Period
Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period
A responder was defined as a subject with a \>= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
Time frame: During the 7-week Treatment Period
Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period
Categories of percentage reductions in seizures from baseline were as following: \< -25 %; -25 % to \<25 %; 25 % to \<75 %; 75 % to \<100 %; 100 %.
Time frame: During the 7-week Treatment Period
Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period
A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.
Time frame: During the 7-week Treatment Period
Number of Seizure-free Days Per 4 Weeks
A day was considered seizure-free, if no seizure was reported during 24 hours.
Time frame: Baseline, during the 7-week Treatment Period
Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period
Number of days to first, fifth, and tenth seizure after baseline.
Time frame: During the 7-week Treatment Period