Dr. Klein and colleagues performed a multicenter, randomized, double-blind, placebo-controlled study. The goal was to analyze the efficacy and safety of brivaracetam, an analog of levetiracetam, in adults with poorly controlled partial-onset seizures.
The researchers administered doses of 100 mg/day or 200 mg/day of brivaracetam as an adjunctive treatment to 764 adults who were taking one or two concurrent antiepileptic drugs (AEDs). More than 80% of participants had failed at least two previous AEDs, and approximately 47% reported failing five or more AEDs. Individuals who had taken levetiracetam within 90 days of study initiation were excluded.
Patients participated in an eight-week baseline period followed by 12 weeks of brivaracetam treatment. After the 12-week treatment period, long-term follow-up was conducted to monitor the drug’s efficacy and safety. Data from seizure diaries indicated a clinically relevant reduction in the frequency of partial-onset seizures during a 28-day period among patients taking either dose of brivaracetam.
Patients taking 100 mg of brivaracetam had a 22.8% reduction in seizure frequency over a 28-day period. This was similar to the 23.2% reduction in seizure frequency observed in patients taking 200 mg of brivaracetam. The findings were consistent regardless of previous levetiracetam exposure.
A total of 23 patients treated with brivaracetam, including 13 (5.4%) taking 100 mg and 10 (4%) taking 200 mg, achieved complete freedom from all seizure types. Two patients in the placebo group achieved seizure freedom.
In general, the treatment was well tolerated. Between 7% and 19% of patients taking 100 mg, and between 8% and 16% of patients taking 200 mg, had adverse events, compared with 3% to 8% of patients in the placebo group. The most common adverse
“Levetiracetam is a great medication that is usually well tolerated, but it has got potential for psychiatric side effects,” said Dr. Klein. Approximately 10% of people receiving levetiracetam have irritability. “The rate of irritability in this study was 2% for both the 100-mg dose and the 200-mg dose, versus 1% for placebo. If brivaracetam turns out to be a more friendly version of levetiracetam, then that would be a helpful thing,” Dr. Klein concluded.
—Erik Greb