Yamaguchi Junya, Ohka Fumiharu, Motomura Kazuya, Ishizaki Tomotaka, Nakahara Norimoto, Fujitani Shigeru, Nagatani Tetsuya, Ohno Masasuke, Ando Masahiko, Kuwatsuka Yachiyo, Nishida Kazuki, Saito Ryuta
Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan.
Department of Neurosurgery, Nagoya Central Hospital, 3-7-7 Taiko, Nakamura-Ku, Nagoya, Aichi, Japan.
Trials. 2024 Dec 24;25(1):849. doi: 10.1186/s13063-024-08693-7.
Early seizures after craniotomy are significant perioperative complications that can adversely impact patient outcomes. Despite current guidelines advising against the routine use of antiseizure drugs for seizure after craniotomy prevention due to limited efficacy data, many clinicians continue prescribing them. This discrepancy highlights the need for robust evidence to guide clinical practice. This multi-center, randomized clinical trial was designed to investigate the efficacy of perampanel in preventing early seizures after craniotomy.
This multi-center, open-label, randomized clinical trial will be conducted across five hospitals in Nagoya, Japan, from February 2024 to December 2026. A total of 142 seizure-naive patients with supratentorial brain tumors will be recruited and randomized (1:1) into the treatment and control groups. The treatment group will receive 2 mg of perampanel starting 2 days preoperatively and continuing for 28 days postoperatively, while the control group will receive no antiseizure drugs. The primary outcome is the incidence of seizures within 28 days after craniotomy. Secondary outcomes are length of hospital and intensive care unit stays and postoperative complications.
This study addresses the critical need for evidence-based recommendations regarding antiseizure drug use for preventing early seizures after craniotomy. As the first multi-center, randomized trial evaluating perampanel's efficacy in this setting, the findings may significantly influence clinical guidelines and perioperative practices.
This trial was registered with the Japan Registry of Clinical Trials (approval number: jRCTs041230117) on December 18, 2023, a member of the Primary Registry Network of the World Health Organization's International Clinical Trials Registry Platform.
开颅术后早期癫痫发作是严重的围手术期并发症，会对患者预后产生不利影响。尽管目前的指南因疗效数据有限，建议不要常规使用抗癫痫药物预防开颅术后癫痫发作，但许多临床医生仍继续开具此类药物。这种差异凸显了需要有力证据来指导临床实践。这项多中心随机临床试验旨在研究吡仑帕奈预防开颅术后早期癫痫发作的疗效。
这项多中心、开放标签、随机临床试验将于2024年2月至2026年12月在日本名古屋的五家医院进行。总共将招募142例幕上脑肿瘤且无癫痫发作史的患者，并将其随机（1:1）分为治疗组和对照组。治疗组将在术前2天开始接受2毫克吡仑帕奈治疗，并在术后持续28天，而对照组将不接受抗癫痫药物治疗。主要结局是开颅术后28天内癫痫发作的发生率。次要结局是住院时间、重症监护病房停留时间和术后并发症。
本研究满足了基于证据的关于使用抗癫痫药物预防开颅术后早期癫痫发作建议的迫切需求。作为首个评估吡仑帕奈在此情况下疗效的多中心随机试验，研究结果可能会对临床指南和围手术期实践产生重大影响。
该试验于2023年12月18日在日本临床试验注册中心注册（批准号：jRCTs041230117），该中心是世界卫生组织国际临床试验注册平台主要注册网络的成员。
