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Researchers Explain Mixed Results From 2 Epilepsy Studies on Brivaracetam BOSTON -- December 18, 2009 -- One study examining the efficacy of brivaracetam, an experimental drug being developed for epilepsy, met its primary endpoint, while another study failed to meet the same primary endpoint of efficacy. In an American study, use of brivaracetam 50 mg was associated with a 12.8% reduction in partial-onset seizures compared with placebo. However in a European study, the drug was associated with only a 6.5% reduction compared with placebo, although the 100 mg dose was associated with an 11.7% reduction in partial-onset seizures, but was not defined as the primary endpoint of the trial. “One speculation as to why there was a difference between trials is that there was a very high rate of success in the placebo group in the European trial,” said Victor Biton, MD, Arkansas Comprehensive Epilepsy Program, Little Rock, Arkansas. Of 400 patients randomised in the US study, 91% completed the 12-week treatment protocol. Of the 399 patients randomised in the EU study, 92% of those included in the intent-to-treat group completed the treatment protocol. In the US study, the median reduction in partial-onset seizures per week at the 50 mg dose was 30.5%, compared with 26.8% in the EU study. However, the 100 mg dose was associated with a 32.5% reduction in seizures per week in the EU study. Four out of 101 patients in the US study receiving brivaracetam 50 mg/day experienced complete freedom from partial-onset seizures from the first day of treatment, compared with none out of 99 patients receiving brivaracetam 50 mg in the EU study. However, 4 out of 100 patients receiving 100 mg in the EU study experienced seizure freedom. Side effects included somnolence, dizziness, and fatigue. Another significant side effect was influenza, which occurred in 6.4% of the drug population, compared with 1% of the placebo group. Results were presented during a poster session at the American Epilepsy Society (AES) 63rd Annual Meeting. Funding for this study was provided by UCB. SOURCE: American Epilepsy Society E-mail this page to a friend or colleague! To print, use this version