Efficacy and Safety of Perampanel as First Adjunctive Therapy in Patients with Partial-Onset Seizures: Post Hoc Analysis of the FAME Study by First-Line Antiepileptic Drug Use
Abstract number :
1.305
Submission category :
7. Antiepileptic Drugs / 7B. Clinical Trials
Year :
2019
Submission ID :
2421300
Source :
www.aesnet.org
Presentation date :
12/7/2019 6:00:00 PM
Published date :
Nov 25, 2019, 12:14 PM
Authors :
#N/A; Dong Wook Kim, Konkuk University School of Medicine, Seoul, Republic of Korea; Hugh J. Lee, Eisai Korea Inc., Seoul, Republic of Korea; Ji-Hyun Kim, Korea University Guro Hospital, Guro-gu, Seoul, Republic of Korea; Amitabh Dash, Eisai Singapore Pte
Rationale: Perampanel is a once-daily oral antiepileptic drug (AED) for partial-onset seizures (POS) and primary generalized tonic-clonic seizures. The efficacy and tolerability of adjunctive perampanel in patients (pts) with uncontrolled epilepsy despite treatment with <=3 AEDs has been demonstrated in three pivotal studies; however, the majority of pts were receiving two or three AEDs during Baseline. FAME (Fycompa as first Add-on to Monotherapy in pts with Epilepsy; Study 412, NCT02726074) investigated the efficacy and safety of perampanel as the first adjunctive therapy in pts aged >=12 years with POS, with or without secondarily generalized seizures (SGS). Here, we present a post hoc subgroup analysis of efficacy and safety outcomes in pts receiving different first-line AEDs during the FAME Study. Methods: FAME was a multicenter, open-label, single-arm, Phase IV study conducted in Korea. Pts were eligible if they required adjunctive therapy after failure to control POS with one AED (at a stable dose for >=8 weeks; dose regimen maintained during study). Pts received perampanel 2 mg/day before up-titration to <=12 mg/day over 12 weeks, followed by a 24-week Maintenance Period. The primary endpoint was the 50% responder rate (proportion of pts achieving a >
Antiepileptic Drugs