Efficacy and Safety of adjunctive Perampanel in a prospective, real‐world, Phase IV study in Indian patients aged ≥12 years for Treatment of focal‐onset Epilepsy: Study 508

Abstract

ObjectiveESPRITE (Study 508; NCT03836924) evaluated the real‐world safety, tolerability, and efficacy of adjunctive perampanel in patients aged ≥12 years with focal‐onset seizures (FOS), with or without focal to bilateral tonic‐clonic seizures (FBTCS), in India.MethodsESPRITE was a prospective, multicenter, single‐arm, observational, Phase IV study with a 6‐month Treatment Period. Patients were aged ≥12 years and had been prescribed perampanel for adjunctive treatment of FOS, with or without FBTCS. Assessments included incidence of treatment‐emergent adverse events (TEAEs; primary endpoint), median percent reduction in seizure frequency per 28 days from baseline, 50% responder rates, and seizure‐freedom rates.ResultsOverall, 200 patients were enrolled (199 patients in the Safety Analysis Set and 174 patients who completed all visits in the main efficacy analyses). TEAEs (all mild or moderate in severity) were reported in 18.1% (n=36/199) of patients (the most common were dizziness [3.0%] and irritability [2.0%]). TEAEs leading to discontinuation of perampanel were reported in 2.0% of patients; no deaths or serious TEAEs occurred. At 6 months, median percent reduction in seizure frequency was 100.0%, 50% responder rate was 83.3%, and seizure‐freedom rate was 49.4%.SignificanceAdjunctive perampanel (at a mean daily dose of 4 mg/day) was shown to be well tolerated and effective in patients aged ≥12 years with FOS, with or without FBTCS, from India.