Over a 12-week treatment period, adjunctive brivaracetam demonstrated efficacy and safety in Asian patients with focal seizure onset.

Among Asian patients with focal onset seizures, brivaracetam, an antiseizure medication, successfully demonstrated efficacy and tolerability compared to placebo, according to study results presented at the American Epilepsy Society (AES) 2023 annual meeting, held from December 1 to 5 in Orlando, Florida

Brivaracetam is approved by the US Food and Drug Administration (FDA) to treat partial-onset seizures in individuals aged 1 month and older. Although the medication’s mechanism of action is unknown, brivaracetam demonstrates a highly selective affinity for the synaptic vesicle protein 2A (SV2A) in the brain, potentially contributing to its anticonvulsant effects.

Previous randomized controlled trials established that the antiseizure medication was efficacious and tolerable in predominantly White/Caucasian patient populations with focal onset seizures.

An international team of researchers across Asia and the US conducted a phase-3, double-blind, randomized, placebo-controlled trial to assess the efficacy and tolerability of adjunctive brivaracetam among 449 Asian patients with focal onset seizures with and without secondary generalization despite treatment with 1 or 2 concomitant antiseizure medications.

Percent reduction in focal seizure frequency/28-days was significantly greater for BRV50 and 200mg than PBO.

After an 8-week baseline period, the researchers randomly assigned 151 patients to receive 50 mg of brivaracetam, 148 patients to receive 200 mg of brivaracetam, and 149 patients to receive placebo. Only 1 patient did not receive 1 or more doses of the assigned trial medications over a 12-week treatment period.

Outcomes of interest included the percent reduction in focal onset seizure frequency over 28-days and a 50% responder rate for focal onset seizure frequency throughout the treatment period.

At baseline, median frequency for focal onset seizures over a 28-day period was 9.0 in the 50 mg group, 7.8 in the 200 mg group, and 9.8 in the placebo group.

After 12 weeks of treatment, compared to patients in the placebo group, those who received mg of brivaracetam demonstrated a 24.6% reduction in focal onset seizure frequency, while patients who received 200 mg of brivaracetam demonstrated a 33.3% reduction over 28 days.

Compared to only 19.0% of patients who received placebo, approximately 41.1% of those who received 50 mg of brivaracetam and 49.3% of those who received 200 mg of brivaracetam achieved a 50% responder rate.

Treatment-emergent adverse events occurred with an incidence of 57.0% in the 50 mg treatment group, 60.1% in the 200 mg treatment group, and 58.4% in the placebo group. During the treatment period, 2.6% of patients in the 50 mg treatment group, 3.4% of patients in the 200 mg treatment group, and 4.7% of patients in the placebo group discontinued treatment secondary to adverse events. The most commonly reported adverse events related to treatment with brivaracetam included somnolence (50/200mg: 9.9%/18.9%) and dizziness (50/200mg: 11.3%/14.2%).

“Adjunctive BRV [brivaracetam] was efficacious and well-tolerated in Asian patients with focal onset seizures,” the researchers concluded. “Percent reduction in focal seizure frequency/28-days was significantly greater for BRV 50 and 200mg than PBO… [while treatment-emergent adverse events] … were similar between treatment groups.”

References:

Moseley B, Tiamkao S, Zhou D, et al. Efficacy and tolerability of adjunctive brivaracetam in Asian patients with focal onset seizures: a phase 3 randomized, placebo-controlled trial. Abstract presented at: AES 2023 Annual Meeting; December 1-5, 2023; Orlando, FL. Abstract #1.286.

 

Source: neurologyadvisor.com, Maria Arini Lopez

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