Study 332 was a double-blind, randomized, placebo-controlled, multicenter, parallel-group trial designed to evaluate the efficacy and safety of adjunctive perampanel therapy in 164 patients aged ≥12 years with uncontrolled PGTC seizures receiving one to a maximum of three anti-epileptic drugs. Patients were randomized to receive perampanel or placebo in a 1:1 ratio. The primary endpoint of a reduction in seizure frequency per 28 days was met based on trial data analysis.
Based on the results of this trial, Eisai plans to submit an application to the FDA in the first half of 2014 for an indication expansion to include the adjunctive treatment of PGTC seizures.
Fycompa (perampanel) is currently approved as an adjunctive treatment for partial-onset seizures with or without secondary generalized seizures in patients with epilepsy aged 12 years and older.
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