Clinical Trial

Biperiden Trial for Epilepsy Prevention

Study acronym: BIPERIDEN
Recruiting Phase 3
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Summary
One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE. In previous studies with animals models of epilepsy, the biperiden decreased the incidence and intensity of spontaneous epileptic seizures besides delaying their appearance. The aim of this study is the evaluation of biperiden as antiepileptogenic drug to prevent PTE and also the determination of side effects, evaluating its cost-effectiveness in patients with moderate and severe TBI.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-06-25; most recent amendment 2024-03-25.
Status change: Not Yet Recruiting → Recruiting 2023-07-24
Trial Details
NCT Number NCT04945213
Lead Sponsor Hospital Sirio-Libanes
Collaborators: PROADI-SUS, Ministry of Health, Brazil, University of Sao Paulo, Santa Casa de Campo Grande, Hospital Sao Rafael, Santa Casa de Misericórdia de Sobral, Hospital São Paulo, Universidade Federal de São Paulo, Instituto Doutor José Frota, Hospital São Vicente de Paulo
Conditions Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Post Traumatic Epilepsy
Enrollment 312 participants
Start Date 2023-01-10
Primary Completion 2026-12-20 (estimated)
Study Completion 2026-12-20 (estimated)
Updated on ClinicalTrials.gov 2024-03-26