A multi-center, open-label, randomized clinical trial evaluating the preventive effect of perampanel on craniotomy-induced epileptogenesis in seizure-naive patients with supratentorial brain tumors: study protocol for a GRAMPAS trial.

Autor: Yamaguchi J; Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan., Ohka F; Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan., Motomura K; Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan., Ishizaki T; Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan., Nakahara N; Department of Neurosurgery, Nagoya Central Hospital, 3-7-7 Taiko, Nakamura-Ku, Nagoya, Aichi, Japan., Fujitani S; Department of Neurosurgery, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, 3-35 Michishita-Cho, Nakamura-Ku, Nagoya, Aichi, Japan., Nagatani T; Department of Neurosurgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, 2-9 Myoken-Cho, Showa-Ku, Nagoya, Aichi, Japan., Ohno M; Department of Neurosurgery, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-Ku, Nagoya, Aichi, Japan., Ando M; Department of Advanced Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan., Kuwatsuka Y; Department of Advanced Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan., Nishida K; Department of Advanced Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan., Saito R; Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan. saito.ryuta.b1@f.mail.nagoya-u.ac.jp.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Dec 24; Vol. 25 (1), pp. 849. Date of Electronic Publication: 2024 Dec 24.
DOI: 10.1186/s13063-024-08693-7
Abstrakt: Background: 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.
Method: 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.
Discussion: 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.
Trial Registration: 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.
Competing Interests: Ethics approval and consent to participate: Ethical approval was granted by the Ethics Committee of Nagoya University Hospital on December 7, 2023 (approval number: 2023-0348). This study has been registered and jRCT (approval number: jRCTs041230117). jRCT is an approved member of the Primary Registry Network of WHO ICTRP. Written informed consent was obtained from all participants. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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