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news.UCB has reported data demonstrating that anti-epileptic drug brivaracetam administered as an adjunctive treatment in adults with refractory epilepsy with partial onset seizures, significantly reduced seizure frequency and had a side-effect profile comparable to placebo.
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The drug has the proposed trade name Rikelta.
The results are compiled from two Phase IIb double-blind, randomized, parallel-group, placebo-controlled dose ranging studies.
The two studies involved 365 patients, aged between 16 and 65, with refractory partial onset seizures, which were uncontrolled despite treatment with one to two other anti-epileptic drugs (AEDs). Patients in the first study were randomized to receive 5mg/day, 20mg/day, 50mg/day or placebo, administered twice-daily without titration over the seven-week treatment period. The study found that brivaracetam reduced weekly seizure frequency over placebo by 9.8%, 14.9% and 22.1% with doses of 5mg/day, 20mg/day and 50mg/day, respectively, suggesting a dose response trend with brivaracetam 5mg/day to 50mg/day.
Patients in the second study were randomized to receive 50mg/day, 150mg/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 50mg/day dose.