Perampanel, a selective, non‐competitive, AMPA receptor antagonist, is approved in >50 countries for adjunctive treatment of partial‐onset seizures (POS), with or without secondarily generalized seizures, and for primary generalized tonic‐clonic seizures in patients with epilepsy aged ≥12 years. In the United States, perampanel was recently approved for monotherapy use for POS in patients with epilepsy aged ≥12 years. Approvals for POS were based on three randomized, double‐blind, placebo‐controlled phase III studies (Studies 304, 305, and 306), in which adjunctive perampanel 4‐12 mg/d reduced the frequency of POS compared with placebo.Study 335 (NCT01618695), a randomized, double‐blind, placebo‐controlled phase III trial, evaluated the efficacy, safety, and tolerability of adjunctive perampanel (4‐12 mg/d) in an Asia‐Pacific population with refractory POS. This study provided an opportunity to explore regional similarities and differences compared with the predominantly Caucasian populations who had participated in Studies 304, 305, and 306. Efficacy and safety outcomes from Study 335 were similar to the previous phase III studies, supporting a consistent profile for perampanel across different populations with POS.In Studies 304 and 305, perampanel 12 mg/d did not appear to offer additional efficacy benefits compared with 8 mg/d, despite the log‐linear relationship between perampanel exposure and efficacy. Therefore, Study 335 explored the perampanel dose‐response relationship
Acta Neurologica Scandinavica – Wiley
Published: Jan 1, 2018
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