Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 3INTERVENTIONAL

Biperiden Trial for Epilepsy Prevention

Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Given willing to sign a consent form - 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, Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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