In:
PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 9 ( 2022-9-9), p. e0273584-
Kurzfassung:
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.
Materialart:
Online-Ressource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0273584
DOI:
10.1371/journal.pone.0273584.g001
DOI:
10.1371/journal.pone.0273584.t001
DOI:
10.1371/journal.pone.0273584.s001
DOI:
10.1371/journal.pone.0273584.s002
DOI:
10.1371/journal.pone.0273584.s003
DOI:
10.1371/journal.pone.0273584.s004
DOI:
10.1371/journal.pone.0273584.s005
DOI:
10.1371/journal.pone.0273584.s006
DOI:
10.1371/journal.pone.0273584.r001
DOI:
10.1371/journal.pone.0273584.r002
DOI:
10.1371/journal.pone.0273584.r003
DOI:
10.1371/journal.pone.0273584.r004
Sprache:
Englisch
Verlag:
Public Library of Science (PLoS)
Publikationsdatum:
2022
ZDB Id:
2267670-3
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