Abstract
Objectives This post hoc analysis examines TEAE rates by Treatment Period in patients aged ≥12 years with newly diagnosed/currently untreated recurrent FOS, with/without focal to bilateral tonic-clonic seizures, who received perampanel monotherapy during Study 342 (FREEDOM; NCT03201900).
Methods During the Core Study, patients received perampanel 4 mg/day (4-week Pretreatment; 32-week Treatment [6-week Titration; 26-week Maintenance]) with the possibility to up-titrate to 8 mg/day. Patients could enter an Extension Phase for an additional 26 weeks (total: 52 weeks). TEAE rates were analysed by Treatment Period (Titration: Weeks 1–3; Steady State: Weeks 4–6; Maintenance: Week 7-end of 4/8-mg/day Maintenance). TEAE rates were calculated as number of events divided by total exposure, multiplied by 100.
Results Eighty-nine treated patients were included in the 4-mg/day group; of these, 21 patients were up-titrated and included in the 8-mg/day group. The rate of TEAEs/100 patient-months was highest during Titration (4 mg/day, 55.0; 8 mg/day, 86.4), lower during Steady State (4 mg/day, 25.2; 8 mg/day, 51.3) and lowest during Maintenance (4 mg/day, 12.4; 8 mg/day, 21.7). Treatment-related TEAEs and serious TEAEs with 4 mg/day exhibited the same pattern; rates with 8 mg/day were more variable. The most common TEAE/100 patient-months during Titration was dizziness (4 mg/day, 18.3; 8 mg/day, 57.6); lower rates of dizziness were reported during Steady State and Maintenance vs Titration.
Conclusions Perampanel monotherapy was generally well tolerated in patients aged ≥12 years with newly diagnosed/currently untreated recurrent FOS; TEAE rates generally decreased over time with treatment.
Funding Eisai Co., Ltd.
