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Biperiden Trial for Epilepsy Prevention
Sponsor: Hospital Sirio-Libanes
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
Biperiden
5mg of biperiden diluted in 100 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV
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