The Phase 3 study was a multicenter, randomize,d double-blind, placebo-controlled study that evaluated adults aged 16–80 years with refractory partial-onset seizures (secondary generalized or not), and not fully controlled despite treatment with one or two concomitant antiepileptic drugs. Patients were randomized to adjunctive brivaracetam 100mg/day or 200mg/day or placebo for a 12-week treatment period after an eight-week prospective baseline period.
The primary efficacy endpoint was the percent reduction in partial-onset seizure frequency per 28 days as compared with placebo. Both study doses of brivaracetam showed statistically significant percent reductions vs. placebo (22.8% [n=252] and 23.2% [n=249], respectively; P<0.001). Also, the 50% responder rate for brivaracetam 100mg/day and 200mg/day were 38.9% (n=98/252) and 37.8% (n=94/249) vs. 21.6% (n=56/259) for placebo (P<0.001 for both).
Brivaracetam is an investigational antiepileptic drug.
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