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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

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 perampane...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10499319/
https://www.ncbi.nlm.nih.gov/pubmed/37712083
http://dx.doi.org/10.3389/fneur.2023.1236046
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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
author_facet 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
author_sort Gao, Lehong
collection PubMed
description 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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spelling pubmed-104993192023-09-14 Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study 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 Front Neurol Neurology 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. Frontiers Media S.A. 2023-08-30 /pmc/articles/PMC10499319/ /pubmed/37712083 http://dx.doi.org/10.3389/fneur.2023.1236046 Text en Copyright © 2023 Gao, Lu, Wang, Yue, Wang, Shao, Guo, Yi, Hong, Jiang, Xiao, Cui, Gao, Hu, Liang, Zhang and Wang. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
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
Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study
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
title_full Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study
title_fullStr Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study
title_full_unstemmed Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study
title_short Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study
title_sort efficacy and safety of perampanel as early add-on therapy in chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10499319/
https://www.ncbi.nlm.nih.gov/pubmed/37712083
http://dx.doi.org/10.3389/fneur.2023.1236046
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