Yamada Shuichi, Nakagawa Ichiro, Kotsugi Masashi, Asada Kiyoshi, Kasahara Masato
Department of Neurosurgery, Nara Medical University, 840 Shijo-cho, Kashihara 634-8522, Nara, Japan.
Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara 634-8522, Nara, Japan.
Methods Protoc. 2024 Oct 5;7(5):79. doi: 10.3390/mps7050079.
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.
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.
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.
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.
中风后癫痫会降低患者进行各种日常生活活动的能力。尽管预防性使用抗癫痫药物在预防中风后癫痫发作方面很重要，但由于缺乏高水平的临床研究，其应用仍存在争议。在本研究中，我们启动了一项针对皮质下出血患者预防性使用抗癫痫药物的前瞻性干预研究，皮质下出血患者是中风后发生癫痫风险最高的人群。
本研究在单中心进行，为无对照组的单臂研究；病例入组期于2023年11月开始，预计2025年3月结束。仅纳入皮质下出血病例。本研究采用的治疗方案为每日服用2毫克吡仑帕奈。吡仑帕奈将服用一年，随后进行两年随访，总研究期为三年。主要终点为癫痫的发生。
与先前关于使用其他治疗方法的报告结果相比，预计服用吡仑帕奈可降低中风后癫痫的发生率。
本研究结果将为预防中风后癫痫提供新的见解。本研究规模相对较小，难以提供吡仑帕奈疗效的确凿证据，但可为更大规模的临床试验提供基础。
