AUTHOR=Gao Lehong , Lu Qiang , Wang Zan , Yue Wei , Wang Guoping , Shao Xiaoqiu , Guo Yi , Yi Yonghong , Hong Zhen , Jiang Yuwu , Xiao Bo , Cui Guiyun , Gao Feng , Hu Jiasheng , Liang Jianmin , Zhang Meiyun , Wang Yuping 

TITLE=Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study

JOURNAL=Frontiers in Neurology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1236046

DOI=10.3389/fneur.2023.1236046

ISSN=1664-2295

ABSTRACT=Background: No interventional study has been conducted in China to assess efficacy and safety of perampanel in treating Chinese patients with epilepsy, nor has there been any study on perampanel early add-on therapy in China. This interventional study aimed to assess efficacy and safety of perampanel as an early add-on treatment of focal-onset seizures (FOS) with or without focal-to-bilateral tonic-clonic seizures (FBTCS) in Chinese patients.In this multicenter, open-label, single-arm, phase 4 interventional study, Chinese patients ≥12 years old with FOS with or without FBTCS who failed anti-seizure medication (ASM) monotherapy from 15 hospitals in China were enrolled and treated with perampanel addon therapy (8-week titration followed by 24-week maintenance). The primary endpoint was 50% responder rate. Secondary endpoints included seizure-freedom rate and changes in seizure frequency from baseline. Treatment-emergent adverse events (TEAEs) and drug-related TEAEs were recorded.The full analysis set included 150 patients. The mean maintenance perampanel dose was 5.9±1.5mg/day and the 8-month retention rate was 72%. The 50% responder rate and seizure-freedom rate for all patients during maintenance were 67.9% and 30.5%, respectively.Patients with FBTCS had higher 50% responder rate (96.0%) and seizure-freedom rate (76.0%) during maintenance. Patients on concomitant sodium valproate had a significantly higher seizure-freedom rate than those on concomitant oxcarbazepine. Eight-six (55.1%) patients experienced treatment-related TEAEs, and the most common TEAEs were dizziness (36.5%), hypersomnia (11.5%), headache (3.9%), somnolence (3.2%), and irritability (3.2%). Withdrawal due to TEAEs occurred to 14.7% of the patients.Perampanel early add-on was effective and safe in treating Chinese patients≥12 years old with FOS with or without FBTCS.