Perampanel Monotherapy in Patients (Pts) with Newly Diagnosed or Currently Untreated Recurrent Partial-Onset Seizures (POS): Efficacy and Safety in the Extension Phase of Study 342 (FREEDOM)
Abstract number :
3.318
Submission category :
7. Antiepileptic Drugs / 7B. Clinical Trials
Year :
2019
Submission ID :
2422212
Source :
www.aesnet.org
Presentation date :
12/9/2019 1:55:12 PM
Published date :
Nov 25, 2019, 12:14 PM
Authors :
#N/A; Yuichi Kubota, TMG Asaka Medical Center, Saitama, Japan; Ji-Hyun Kim, Korea University Guro Hospital, Seoul, Republic of Korea; Sung Chul Lim, The Catholic University of Korea, St. Vincent Hospital, Gyeonggi-do, Republic of Korea; Hirotomo Ninomiya,
Rationale: Perampanel is a once-daily oral anti-seizure drug for POS and primary generalized tonic-clonic seizures. Study 342 (NCT03201900; FREEDOM), a multicenter, uncontrolled, open-label Phase III study, is currently assessing the efficacy and safety of perampanel monotherapy in pts with newly diagnosed or currently untreated recurrent POS with or without secondarily generalized (SG) seizures in Japan and South Korea. Here we report efficacy and safety data from the ongoing Extension Phase of Study 342. Methods: Study 342 involves pts aged 12-74 years with POS with or without SG seizures. The Core Study consisted of 4-week Pretreatment and 32-week Treatment (6-week Titration; 26-week Maintenance) Phases; pts were titrated to perampanel 4 mg/day. If pts experienced seizures during the 4 mg/day Maintenance Period, they could enter an additional 30-week Treatment Phase (4-week Titration; 26-week Maintenance) and receive perampanel <=8 mg/day. Pts who completed the Core Study could enter the 26-week Extension Phase during which dose adjustment (2-8 mg/day) was allowed based on clinical response and/or tolerability. Efficacy endpoints include seizure-freedom rate during 52 weeks of treatment and time to first seizure onset. Treatment-emergent adverse events (TEAEs) are being monitored. Results: Ninety one pts entered the Core Study Treatment Phase; 89 received >
Antiepileptic Drugs