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RECRUITING
NCT04945213
PHASE3

Biperiden Trial for Epilepsy Prevention

Sponsor: Hospital Sirio-Libanes

View on ClinicalTrials.gov

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.

Official title: Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

312

Start Date

2023-01-10

Completion Date

2026-12-20

Last Updated

2024-03-26

Healthy Volunteers

No

Interventions

DRUG

Biperiden

5mg of biperiden diluted in 100 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV

OTHER

Placebo

1ml sterile vehicle (sodium lactate, lactic acid, sodium hydroxide and water for injections) diluted in 100 ml 0.9% saline - every 6 hours for 10 consecutive days - IV

Locations (10)

Instituto Doutor José Frota

Fortaleza, Ceará, Brazil

Santa Casa de Misericórdia de Sobral

Sobral, Ceará, Brazil

Hospital Estadual Urgencia e Emergencia -HEUE

Vitória, Espírito Santo, Brazil

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Associação Beneficente Santa Casa de Campo Grande

Campo Grande, Mato Grosso do Sul, Brazil

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Hospital Sirio-Libanes

São Paulo, Brazil

Hospital São Paulo, Universidade Federal de São Paulo

São Paulo, Brazil