55.8% of patients, for 5mg/day, 20mg/day and 50mg/day, respectively,
compared to 16.7% for placebo.
-- Produced seizure freedom rates of 7.7% for 20 mg-50 mg/day, 8% for
5mg/day and 1.9% for placebo over the treatment period.
Patients in the second study (Abstract 3.218) were randomized to
receive 50 mg/day, 150 mg/day, or placebo, administered twice-daily without
titration over the 12 week treatment period. The findings for the study's
primary endpoint-reduction in weekly seizure frequency over placebo-were
not statistically significant. However, an analysis of the study's
secondary endpoints demonstrated a clear difference between placebo and the
50 mg/day dose:
-- The median difference versus placebo for the percent reduction from
baseline in seizure frequency per week was 22.5%.
-- There was at least a 50% reduction in weekly seizure frequency from
baseline in 39.6% of patients, compared with 23.1% for placebo.
-- Seizure freedom rates of 9.4% were seen for 50mg/day, compared with
1.9% for placebo.
Retention rates in both studies were high and similar to placebo, with up to 98% of patients in the treatment group completing the studies. The most commonly reported adverse events were nausea, vomiting, fatigue, nasopharyngitis, anorexia, convulsion, dizziness, headache, somnolence, and insomnia. A dose-response relationship was not observed for the majority of adverse events analyzed in the studies.
Phase III clinical trials of brivaracetam as adjunctive therapy in
patients with refractory partial onset epilepsy are already underway.
Nearly 1,300 epilepsy patients, ages 16-70, will take part in three
multicenter, multinational phase III trials. Two randomized, double-blind,
placebo- controlled studies are designed to evaluate the efficacy and
safety of brivaracetam (5, 20 and 50 mg/day or 20, 50 and 100 mg/day) over
12 weeks in patients with partial onset epilepsy, no
|SOURCE UCB, Inc.|
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