Biperiden for prevention of post-traumatic epilepsy: A protocol of a double-blinded placebo-controlled randomized clinical trial (BIPERIDEN trial).

Autor: Foresti ML; Neurology Neuroscience Postgraduation Program, Physiology Department, Universidade Federal de São Paulo, São Paulo, Brasil.; Sociedade Beneficente de Senhoras Hospital Sírio-Libanês, São Paulo, SP, Brazil.; Instituto D'Or de Pesquisa e Ensino, São Paulo, SP, Brasil., Garzon E; Sociedade Beneficente de Senhoras Hospital Sírio-Libanês, São Paulo, SP, Brazil.; Department of Neurology, Division of Neurologic Clinic, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo-SP, Brazil., Pinheiro CCG; Sociedade Beneficente de Senhoras Hospital Sírio-Libanês, São Paulo, SP, Brazil., Pacheco RL; Departamento de Medicina, Centro Universitário São Camilo, São Paulo, SP, Brazil.; Center of Health Technology Assessment, Sociedade Beneficente de Senhoras Hospital Sírio-Libanês, São Paulo, SP, Brazil., Riera R; Center of Health Technology Assessment, Sociedade Beneficente de Senhoras Hospital Sírio-Libanês, São Paulo, SP, Brazil.; Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil., Mello LE; Neurology Neuroscience Postgraduation Program, Physiology Department, Universidade Federal de São Paulo, São Paulo, Brasil.; Sociedade Beneficente de Senhoras Hospital Sírio-Libanês, São Paulo, SP, Brazil.; Instituto D'Or de Pesquisa e Ensino, São Paulo, SP, Brasil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 Sep 09; Vol. 17 (9), pp. e0273584. Date of Electronic Publication: 2022 Sep 09 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0273584
Abstrakt: Background: Traumatic brain injury (TBI) is one of the most important causes of acquired structural epilepsy, post-traumatic epilepsy (PTE), however, efficient preventative measures and treatment are still not available to patients. Preclinical studies indicated biperiden, an anticholinergic drug, as a potential drug to modify the epileptogenic process. The main objective of this clinical trial is to evaluate the efficacy of biperiden as an antiepileptogenic agent in patients that suffered TBI.
Methods: This prospective multicenter (n = 10) interventional study will include 312 adult patients admitted to emergency care units with a diagnosis of moderate or severe TBI. Following inclusion and exclusion criteria, patients will be randomized, using block randomization, to receive double-blind treatment with placebo or biperiden for 10 days. Follow-up will occur at specific time windows up to 2 years. Main outcomes are incidence of PTE after TBI and occurrence of severe adverse events. Other outcomes include exploratory investigation of factors that might have benefits for the treatment or might influence its results, such as genetic background, clinical progression, electroencephalographic abnormalities, health-related quality of life and neuropsychological status. Analyses will be conducted following the safety, intention-to-treat and efficacy concepts.
Discussion: We hypothesize that biperiden treatment will be effective to prevent or mitigate the development of post-traumatic epilepsy in TBI patients. Other health measures from this population also may benefit from treatment with biperiden.
Trial Registration: ClinicalTrials.gov, NCT04945213. Registered on June 30, 2021.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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