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Biperiden Trial for Epilepsy Prevention

RecruitingPhase 3Ages 18 Years - 75 YearsAllHospital Sirio-Libanes
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Biperiden
  • Placebo
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Where

10 sites
Instituto Doutor José Frota
Fortaleza, Brazil
Santa Casa de Misericórdia de Sobral
Sobral, Brazil
Hospital Estadual Urgencia e Emergencia -HEUE
Vitória, Brazil
Hospital São Rafael
Salvador, Brazil
Associação Beneficente Santa Casa de Campo Grande
Campo Grande, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão Preto
Ribeirão Preto, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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