Long-term Efficacy of Perampanel Monotherapy in Patients with Newly Diagnosed/currently Untreated Recurrent Focal-onset Seizures: FREEDOM Study 342 Extension Phase Analysis by Seizure Type
Abstract number :
2.228
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2022
Submission ID :
2204587
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:25 AM
Authors :
Sung Chul Lim, MD, PhD – The Catholic University of Korea; Anna Patten, PhD – Eisai Ltd.; Marcia Morita-Sherman, MD, PhD – Eisai Inc.; Leock Ngo, PhD – Eisai Inc.; Takamichi Yamamoto, MD, MS, PhD, FAES – Seirei Hamamatsu General Hospital
Rationale: In the U.S., Japan, and Korea, perampanel is approved as monotherapy and adjunctive therapy for focal-onset seizures (FOS), with or without focal to bilateral tonic-clonic seizures (FBTCS), in patients aged ≥ 4 years, and adjunctive treatment of generalized tonic-clonic seizures in patients aged ≥ 12 (≥ 7, Korea) years. Findings from FREEDOM (Study 342; NCT03201900) demonstrated that 52 weeks’ maintenance therapy with perampanel monotherapy (4 to 8 mg/day) was efficacious and well tolerated in patients aged ≥ 12 years from Japan and Korea with newly diagnosed or currently untreated recurrent FOS, with or without FBTCS. Here, we report the 52-week results of a post hoc analysis that assessed perampanel monotherapy efficacy by seizure type._x000D_
Methods: During the Core Study, patients received perampanel 4 mg/day (4-week Pretreatment Period; 32-week Treatment [comprising a 6-week Titration Period and a 26-week Maintenance Period]). Patients who experienced seizure(s) during the 4-mg/day Maintenance Period could be transitioned to an additional 30-week 8-mg/day Treatment Phase (comprising a 4-week Titration Period and a 26-week Maintenance Period) per the investigator’s discretion. Patients could enter a 26‑week Extension Phase to continue treatment with perampanel monotherapy after completion of the Core Study Treatment Phase. The 52-week seizure-freedom rates were assessed by seizure type (focal impaired awareness [FIAS], FBTCS, and FOS).
Results: Overall, 89 patients received ≥ 1 dose of perampanel (defined as Safety Analysis Set) and 73 patients entered the 4-mg/day Maintenance Period (defined as the modified Intent-to-Treat [mITT] Analysis Set), of whom 21 patients experienced ≥ 1 seizure during the 4-mg/day Treatment Phase and so entered the 8-mg/day Treatment Phase. In the Safety Analysis Set, the mean (standard deviation [SD]) duration of perampanel exposure was 66.5 (52.0) weeks across Core Study and Extension Phase. In the mITT population, the mean (SD) age was 41.7 (18.5) years, and the majority of patients had newly diagnosed epilepsy (95.9% [n=70/73]). The 52-week seizure-freedom rates for perampanel monotherapy 4 mg/day were 34.1% for FIAS, 31.3% for FBTCS, and 32.9% for FOS (with or without FBTCS); these rates at last evaluated dose (4 or 8 mg/day) were 41.5% (FIAS), 43.8% (FBTCS), and 42.9% (FOS with or without FBTCS) (Figure 1).
Conclusions: These results suggest that seizure freedom can be achieved and sustained with perampanel monotherapy treatment (4 to 8 mg/day) long term (up to 52 weeks).
Funding: Eisai Co., Ltd.
Anti-seizure Medications