Study 410, a 12-month, multicenter, open-label, Phase IV study, comprises Screening (≤6 weeks prior to first perampanel dose), 13-week Titration, 39-week Maintenance, and Follow-up Periods (approximately 4 weeks following last perampanel dose). Approximately 300 patients with epilepsy are planned for enrollment at ≤60 sites across the US and other countries (to be identified). Perampanel will be provided as tablets at the assigned dose and administered orally once daily before bedtime. During Titration, perampanel will be taken at 2 mg/day and initially up-titrated to 4 mg/day based on clinical response and tolerability; patients can receive ≤12 mg/day depending on need for additional efficacy. The primary endpoint is retention rate (proportion of patients remaining on perampanel at 3, 6, 9, and 12 months after treatment initiation) assessed using exposure data. Secondary endpoints will assess efficacy and safety.

Study 410 will provide an overview of retention rates, and efficacy and safety data for perampanel as monotherapy or first adjunctive therapy in patients (aged ≥12 years) with POS, with/without SG seizures, or PGTCS.

Funding: Eisai Inc.