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

Autor:	Yamada S; Department of Neurosurgery, Nara Medical University, 840 Shijo-cho, Kashihara 634-8522, Nara, Japan., Nakagawa I; Department of Neurosurgery, Nara Medical University, 840 Shijo-cho, Kashihara 634-8522, Nara, Japan., Kotsugi M; Department of Neurosurgery, Nara Medical University, 840 Shijo-cho, Kashihara 634-8522, Nara, Japan., Asada K; Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara 634-8522, Nara, Japan., Kasahara M; Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara 634-8522, Nara, Japan.
Jazyk:	angličtina
Zdroj:	Methods and protocols [Methods Protoc] 2024 Oct 05; Vol. 7 (5). Date of Electronic Publication: 2024 Oct 05.
DOI:	10.3390/mps7050079
Abstrakt:	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.
Databáze:	MEDLINE
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