Biperiden Trial for Epilepsy Prevention
Recruiting · NCT04945213 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Sirio-Libanes
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Given informed consent
- 18 - 75 years of age
- GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene with previous GCS between 6 and 15.
- Moderate or severe acute traumatic brain injury
- All genders
- Brain CT scan with signs of of acute intraparenchymal hemorrhage and/or contusion
- Able to receive the first dose of treatment or placebo within 18 hours of brain injury,
Exclusion criteria
- Previous use of biperiden
- History of epilepsy (confirmed by patient chart)
- History of seizures or use of antiepileptic medication
- Pregnancy
- Participation in another clinical trial at the time of randomization
- History of neoplasia, neurodegenerative diseases; history of stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or any other cardiac arrhythmia, or glaucoma megacolon or mechanical obstruction
- Homeless patient
Where it is running
10 locations listed.
- Hospital Sirio-Libanes - São Paulo, Brazil
- Hospital São Paulo, Universidade Federal de São Paulo - São Paulo, Brazil
- 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