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Adjunctive brivaracetam for refractory partial-onset seizures: a randomized, controlled trial.

J A French¹, C Costantini, A Brodsky

¹NYU Comprehensive Epilepsy Center, New York, NY 10016, USA. jacqueline.french@nyumc.org

|July 2, 2010

Summary

Adjunctive brivaracetam (BRV) effectively reduced partial-onset seizures (POS) in patients with epilepsy. The study found BRV to be safe and well-tolerated, offering a new treatment option for refractory POS.

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Area of Science:

Neurology
Pharmacology
Clinical Trials

Background:

Epilepsy characterized by partial-onset seizures (POS) often requires adjunctive therapy.
Brivaracetam (BRV), a novel synaptic vesicle protein 2A ligand, inhibits voltage-dependent sodium channels.
Investigating BRV's efficacy and safety in refractory POS is crucial.

Purpose of the Study:

To evaluate the efficacy and safety of adjunctive brivaracetam (BRV) in patients with refractory partial-onset seizures (POS).
To determine optimal dosing for BRV in this patient population.

Main Methods:

Phase IIb, double-blind, randomized, placebo-controlled, dose-ranging study.
208 patients aged 16-65 with refractory POS received placebo, BRV 5 mg/day, BRV 20 mg/day, or BRV 50 mg/day BID for 7 weeks.
Primary endpoint: reduction in POS frequency/week compared to placebo.

Main Results:

Brivaracetam demonstrated dose-dependent reductions in POS frequency.
BRV50 showed a statistically significant 22.1% reduction in POS frequency versus placebo (p=0.004).
Higher responder rates and median reductions in POS frequency were observed with increasing BRV doses; BRV was well-tolerated with infrequent adverse events.

Conclusions:

Adjunctive brivaracetam (BRV) is efficacious and well-tolerated for treating refractory partial-onset seizures (POS) in patients aged 16-65.
Preliminary Class I evidence supports BRV as a viable treatment option.
Further research may confirm BRV's role in epilepsy management.