Time to exceed pre-randomization monthly seizure count for perampanel in participants with primary generalized tonic–clonic seizures: A potential clinical end point

Abstract

Objective: To evaluate the exploratory time to exceed pre-randomization seizure count (T-PSC) in the determination of efficacy of adjunctive perampanel in participants with primary generalized tonic–clonic (PGTC) seizures in generalized-onset epilepsy. Methods: In this multicenter, double-blind study (ClinicalTrials.gov identifier: NCT01393743), participants ≥12 years of age with treatment-resistant idiopathic generalized epilepsy were randomized to receive placebo or adjunctive perampanel (≤8 mg/day) across a 17-week double-blind treatment phase (4-week titration; 13-week maintenance). We evaluated the pre-planned exploratory end point of the T-PSC using a Kaplan–Meier analysis. We also re-evaluated the correspondence of the primary end points of median percent seizure frequency change (MPC) and 50% responder rate (50RR) calculated at T-PSC and at the end of the trial. Results: The exploratory end point of median T-PSC on placebo was 43 days and >120 days on perampanel (log-rank p