Perampanel in Older Adult Patients Receiving Perampanel as First or Second Adjunctive Therapy: An Overview of Data from Studies 412 and 501
Abstract number :
2.22
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2022
Submission ID :
2204563
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:25 AM
Authors :
Dong Wook Kim, MD – Konkuk University School of Medicine, Seoul, Republic of Korea; Francesca Bisulli, MD, PhD – Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy; Anna Gentile, PhD – Eisai s.r.l., Milan, Italy; Samantha Goldman, MD, B.Sc (Hons) – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Anna Patten, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Amitabh Dash, MD – Eisai Singapore Pte., Ltd., Singapore; Ji Woong Lee, BPharm – Eisai Korea Inc., Seoul, Republic of Korea; Ricardo Sáinz-Fuertes, LMS, MSc, MRCPsych, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK
Rationale: Epilepsy incidence is higher in the older adult population than the general population. Aging populations may therefore expect rising numbers of patients with epilepsy. Perampanel is a once-daily oral anti-seizure medication (ASM) for focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), and generalized tonic-clonic seizures. Here, we provide an overview of perampanel efficacy and safety data in older adult patients (aged ≥ 60 years) from Studies 412 (NCT02726074; FAME; Korea) and 501 (NCT04257604; AMPA; Italy) who received perampanel as a first or second adjunctive ASM.
Methods: Patients in Studies 412 and 501 were aged ≥ 12 years with FOS, with/without FBTCS. In the Phase IV Study 412, patients received open-label perampanel as first adjunctive therapy (up to 12 mg/day; 12-week Titration; 24-week Maintenance). Study 501 included patients prescribed perampanel (up to 12 mg/day) during routine clinical care over 12 months. Primary endpoints were 50% responder rate (Study 412) and median percent change in seizure frequency/28 days at Month 6 (Study 501); secondary/exploratory endpoints included 75% responder rates, seizure-freedom rates, and treatment-emergent adverse events (TEAEs). Only patients aged ≥ 60 years receiving perampanel as first or second adjunctive therapy were included in these post hoc analyses.
Results: In Study 412, 15 patients with FOS were aged ≥ 60 years and were included in the Safety Analysis Set (n=13; Full Analysis Set). In Study 501, 19 patients were aged ≥ 60 years and received perampanel as first or second adjunctive therapy (Safety Analysis Set), of whom 13 were included in the Full Analysis Set (Intent-to-Treat). In Study 501, median reduction in all-seizure frequency was 67.2% and 85.8% at Months 6 and 12, respectively. The 50% and 75% responder rates and seizure-freedom rates are presented in Figure 1. In Study 412, 50% responder rate (24-week Maintenance Period) was 12/13 (92.3%); in Study 501, this was 50.0% and 66.7% for all seizures at Months 6 and 12, respectively. A summary of TEAEs in Studies 412 and 501 is presented in Table 1. The most common TEAE in both studies was dizziness (Study 412, 40.0% [n=6/15]; Study 501, 26.3% [n=5/19]).
Conclusions: Based on the available data from Studies 412 and 501, perampanel was found to be efficacious and generally safe and well tolerated in older adult patients receiving perampanel as a first or second adjunctive ASM. These data support the use of perampanel as an early-line treatment option for older patients with FOS, with/without FBTCS.
Funding: Eisai Korea Inc., Eisai s.r.l., Eisai Inc.
Anti-seizure Medications