Efficacy and safety of new anti-epileptic drug revealed by phase III study

Researchers from the Mid-Atlantic Epilepsy and Sleep Center and other participating medical centers performed a randomized, double-blind, placebo-controlled study in the United States and Europe on the efficacy and safety of the drug brivaracetam, an analog of the commonly used AED levetiracetam, in adults with poorly controlled partial onset seizures.

"This first presentation of primary study results from the latest Phase 3 brivaracetam study is highly anticipated in the epilepsy community. The two primary outcomes in this study evaluating adjunctive brivaracetam in the treatment of partial-onset seizures in adults with epilepsy were statistically significant and clinically relevant," said Dr. Pavel Klein, director, Mid-Atlantic Epilepsy and Sleep Center.

The authors evaluated fixed doses of 100mg/day or 200 mg/day brivaracetam as an adjunctive treatment in 764 adults who were taking one or two concurrent AEDs. More than 80% of the patients had failed at least two previous epilepsy medications, and approximately 47% reported failing 5 or more AEDs.

After participating in an 8-week baseline period followed by 12 weeks of brivaracetam treatment, patients became eligible for long-term follow-up to monitor the drug's efficacy and safety. Data obtained from seizure diaries reveal a clinically relevant reduction in the frequency of partial onset seizures during a 28-day period in patients taking either dose of brivaracetam, relative to a placebo.

Patients taking 100 mg brivaracetam experienced a 22.8% decline in seizure frequency over a 28-day period, similar to the 23.2% reduction observed in patients taking 200 mg brivaracetam. The findings remained consistent regardless of prior levetiracetam exposure, the authors report.

Complete freedom from all seizure types was achieved in 23 patients treated with brivaracetam, including 13 (5.4%) taking 100 mg and 10 (4%) taking 200 mg. Two patients achieved this status in the placebo group.

In general, the treatment was well tolerated, the authors report. Adverse events -- most commonly dizziness, fatigue, headache and sleepiness -- occurred in 7-19% of patients taking 100 mg and 8-16% of patients taking 200 mg brivaracetam, compared with 3-8% of patients in the placebo group.

According to the authors, the study reveals that brivaracetam daily doses of 100 mg and 200 mg are generally well tolerated and may help reduce seizure frequency when administered as adjunctive therapy in adult epilepsy patients with partial onset seizures.