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| |  Mixed Results for Adjunctive Brivaracetam in Patients With Refractory Partial-Onset Seizures: Presented AES By John Otrompke BOSTON -- December 6, 2009 -- Brivaracetam, an experimental epilepsy drug, met its primary efficacy endpoint in 1 trial, but failed to meet the same endpoint in another trial, according to a poster presented here at the American Epilepsy Society (AES) 63rd Annual Meeting. Use of adjunctive brivaracetam, a novel high-affinity synaptic vesicle protein 2A ligand, was associated with a significant 12.8% reduction in partial-onset seizures over placebo at a 50-mg QD dose in a US study (P = .025), but was associated with only a 6.5% reduction compared with placebo in a European study, which was not considered statistically significant. However, in the European trial, the 100-mg QD dose was associated with a significant 11.7% reduction in partial-onset seizures (P = .037), but this 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, who presented the poster findings on December 5. Of 400 patients randomised in the US study, 91% completed the 12-week treatment protocol. Of 399 patients randomised in the European study, 92% of those included in the intent-to-treat group completed the treatment protocol. In the American study, patients treated with brivaracetam 50 mg achieved a 30.5% median reduction in partial-onset seizures per week (P = .003). In the European study, the median reduction was only 26.8% (P = .092). However, brivaracetam 100 mg was associated with a 32.5% reduction in seizures per week in the European study (P = .004). Four out of 101 US patients in the 50-mg QD group experienced complete freedom from partial-onset seizures from the first day of treatment, compared with none out of 99 patients in the 50-mg QD group in the European study. However, 4 out of 100 European patients treated with the 100-mg dose experienced seizure freedom. Side effects included somnolence (15.1% vs 7.1% for placebo), dizziness (14.1% vs 9.2%), fatigue (8.7% vs 2%). Another significant side effect was influenza, which occurred in 6.4% of the drug population, compared with 1% of the placebo group. Four deaths occurred during the studies, including 1 in the placebo group. Dr. Biton explained the mechanism of action of the drug. “Chemicals which allow an electric signal to jump from one nerve to the other are stored in vesicles, and this drug has an effect on the membrane of that vesicle,” he explained. [Presentation title: Brivaracetam as Adjunctive Treatment of Refractory Partial-Onset Seizures in Adults: Results From Two Randomized, Double-Blind, Placebo-Controlled Trials. Abstract 1.216]
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