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

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收录情况： ◇ SCIE

作者：
Gao Lehong[1] * ; Lu Qiang[2] ; Wang Zan[3] ; Yue Wei[4] ; Wang Guoping[5] ; Shao Xiaoqiu[6] ; Guo Yi[7] ; Yi Yonghong[8] ; Hong Zhen[9] ; Jiang Yuwu[10] ; Xiao Bo[11] ; Cui Guiyun[12] ; Gao Feng[13] ; Hu Jiasheng[14] ; Liang Jianmin[15] ; Zhang Meiyun[16] ; Wang Yuping[1,17,18,19] ;
机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [2]Department of Neurology, Peking Union Medical College Hospital, Beijing, China. [3]Department of Neurology, The First Hospital of Jilin University, Changchun, China. [4]Department of Neurology, Tianjin Huanhu Hospital, Tianjin, China. [5]Division of Life Sciences and Medicine, Department of Neurology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China. [6]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. [7]Department of Neurology, Shenzhen People's Hospital, The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology, Shenzhen, China. [8]Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Department of Neurology, Institute of Neuroscience, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [9]Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China. [10]Department of Pediatrics and Pediatric Epilepsy Center, Peking University First Hospital, Beijing, China. [11]Department of Neurology, Xiangya Hospital, Central South University, Changsha, China. [12]Department of Neurology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. [13]Department of Neurology, Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China. [14]Department of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [15]Department of Pediatric Neurology, The First Hospital of Jilin University, Changchun, China. [16]Department of Neurology, Tianjin Union Medical Center, Tianjin, China. [17]Beijing Key Laboratory of Neuromodulation, Beijing, China. [18]Center of Epilepsy, Institute of Sleep and Consciousness Disorders, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China. [19]Neuromedical Technology Innovation Center of Hebei Province, Hebei Hospital of Xuanwu Hospital, Capital Medical University, Shijiazhuang, China.
出处：
DOI： 10.3389/fneur.2023.1236046
ISSN：

关键词： perampanel focal-onset seizures Chinese patients perampanel early add-on 50% responder rate seizure-freedom rate perampanel seizure-freedom rate

摘要：
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 add-on 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 ± 1.5 mg/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.Clinical trial registrationwww.chictr.org.cn, Identifier ChiCTR2000039510.Copyright © 2023 Gao, Lu, Wang, Yue, Wang, Shao, Guo, Yi, Hong, Jiang, Xiao, Cui, Gao, Hu, Liang, Zhang and Wang.

语种：
外文
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中科院(CAS)分区：
出版当年[2022]版：
大类 | 3 区 医学
小类 | 3 区 神经科学 3 区 临床神经病学
最新[2023]版：
大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学
JCR分区：
出版当年[2021]版：
Q2 CLINICAL NEUROLOGY Q2 NEUROSCIENCES
最新[2023]版：
Q2 CLINICAL NEUROLOGY Q3 NEUROSCIENCES

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
通讯作者：
通讯机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [17]Beijing Key Laboratory of Neuromodulation, Beijing, China. [18]Center of Epilepsy, Institute of Sleep and Consciousness Disorders, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China. [19]Neuromedical Technology Innovation Center of Hebei Province, Hebei Hospital of Xuanwu Hospital, Capital Medical University, Shijiazhuang, China.
推荐引用方式(GB/T 7714)：
Gao Lehong,Lu Qiang,Wang Zan,et al.Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study[J].FRONTIERS IN NEUROLOGY.2023,14:doi:10.3389/fneur.2023.1236046.
APA：
Gao Lehong,Lu Qiang,Wang Zan,Yue Wei,Wang Guoping...&Wang Yuping.(2023).Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study.FRONTIERS IN NEUROLOGY,14,
MLA：
Gao Lehong,et al."Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study".FRONTIERS IN NEUROLOGY 14.(2023)

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