Prophylactic Administration of Perampanel for Post-Stroke Epilepsy (PROPELLER Study): A Trial Protocol.

IF 2.3 Q3 BIOCHEMICAL RESEARCH METHODS
Shuichi Yamada, Ichiro Nakagawa, Masashi Kotsugi, Kiyoshi Asada, Masato Kasahara
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Abstract

Background: Post-stroke epilepsy can reduce patients' abilities to carry out various activities of daily living. Despite their importance in preventing the onset of post-stroke epilepsy, the prophylactic administration of antiepileptic drugs is controversial due to a lack of high-level clinical research. In this study, we initiated a prospective interventional study of prophylactic antiepileptic drug administration in patients with a subcortical hemorrhage, who are at the highest risk of developing epilepsy after experiencing a stroke.

Methods: The study was conducted in a single-center setting and was a single-arm study with no control group; the case entry period started in November 2023 and is due to end in March 2025. Only cases with a subcortical hemorrhage will be included. The treatment regimen used in this study is 2 mg of perampanel per day. Perampanel will be administered for one year, followed by two years of follow-up, for a total study period of three years. The primary endpoint will be the development of epilepsy.

Results: Perampanel administration is expected to reduce the incidence of post-stroke epilepsy in comparison to the results of previous reports on the use of alternative treatments.

Conclusions: The results of this study will provide new insights into the prevention of post-stroke epilepsy. The relatively small size of this study makes it difficult to provide strong evidence of the efficacy of perampanel, but it may serve as a basis for larger clinical trials.

中风后癫痫预防性用药 Perampanel(PROPELLER 研究):试验方案。
背景:脑卒中后癫痫会降低患者进行各种日常生活活动的能力。尽管抗癫痫药物对预防脑卒中后癫痫的发生非常重要,但由于缺乏高水平的临床研究,预防性服用抗癫痫药物仍存在争议。在本研究中,我们启动了一项前瞻性干预研究,针对脑皮层下出血患者预防性服用抗癫痫药物,这些患者在中风后患癫痫的风险最高:该研究在单中心环境下进行,是一项单臂研究,不设对照组;病例输入期从 2023 年 11 月开始,将于 2025 年 3 月结束。只有皮层下出血的病例才会被纳入。本研究采用的治疗方案为每天 2 毫克 perampanel。佩兰帕奈的疗程为一年,随后进行两年的随访,总研究期为三年。主要终点是癫痫的发生:结果:与之前关于使用替代疗法的报告结果相比,服用培南帕奈有望降低中风后癫痫的发病率:本研究的结果将为预防中风后癫痫提供新的见解。由于这项研究的规模相对较小,因此很难为perampanel的疗效提供有力的证据,但它可以作为更大规模临床试验的基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Methods and Protocols
Methods and Protocols Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (miscellaneous)
CiteScore
3.60
自引率
0.00%
发文量
85
审稿时长
8 weeks
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