Actively Recruiting
Biperiden Trial for Epilepsy Prevention
Led by Hospital Sirio-Libanes · Updated on 2024-03-26
312
Participants Needed
10
Research Sites
205 weeks
Total Duration
On this page
Sponsors
H
Hospital Sirio-Libanes
Lead Sponsor
P
PROADI-SUS
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Biperiden Trial for Epilepsy Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Given informed consent
- Between 18 and 75 years of age
- Glasgow Coma Scale (GCS) between 6 and 12 at hospital admission, or between 3 and 5 if sedated with previous GCS between 6 and 15
- Diagnosed with moderate or severe acute traumatic brain injury
- All genders
- Brain CT scan showing acute intraparenchymal hemorrhage and/or contusion
- Able to receive the first dose of treatment or placebo within 18 hours of brain injury
You will not qualify if you...
- Previous use of biperiden
- History of epilepsy confirmed by medical records
- History of seizures or current use of antiepileptic medication
- Pregnancy
- Currently participating in another clinical trial
- History of cancer, neurodegenerative diseases, stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or other cardiac arrhythmias, glaucoma, megacolon, or mechanical obstruction
- Homelessness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Instituto Doutor José Frota
Fortaleza, Ceará, Brazil
Not Yet Recruiting
2
Santa Casa de Misericórdia de Sobral
Sobral, Ceará, Brazil
Actively Recruiting
3
Hospital Estadual Urgencia e Emergencia -HEUE
Vitória, Espírito Santo, Brazil
Not Yet Recruiting
4
Hospital São Rafael
Salvador, Estado de Bahia, Brazil
Actively Recruiting
5
Associação Beneficente Santa Casa de Campo Grande
Campo Grande, Mato Grosso do Sul, Brazil
Actively Recruiting
6
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Active, Not Recruiting
7
Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Actively Recruiting
8
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Actively Recruiting
9
Hospital Sirio-Libanes
São Paulo, Brazil, 01308-000
Actively Recruiting
10
Hospital São Paulo, Universidade Federal de São Paulo
São Paulo, Brazil
Not Yet Recruiting
Research Team
E
Eliana Garzon, MD, PhD
CONTACT
M
Maira L Foresti, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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