[Non-epileptic disorders in infancy and adolescence].
Sergio A Antoniuk
https://pubmed.ncbi.nlm.nih.gov/24072054Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID04945213
Biperiden for Prevention of Epilepsy in Patients With Moderate or Severe Traumatic Brain Injury
Led by Hospital Sirio-Libanes · Updated on 2024-03-26
312
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospital Sirio-Libanes
Lead Sponsor
P
PROADI-SUS
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying biperiden as a potential preventive treatment for post traumatic epilepsy (PTE), a common neurological complication after moderate or severe traumatic brain injury (TBI). This research aims to evaluate if biperiden can reduce the occurrence of PTE, assess its side effects, and analyze its cost-effectiveness. The trial focuses on adult patients with moderate or severe TBI, as PTE often develops within two years after injury and currently lacks effective prevention. Participants are randomly assigned to receive either 5 mg of biperiden intravenously every 6 hours for 10 days or a placebo with similar administration. The treatment starts within 18 hours of brain injury. The study includes a two-year follow-up period with regular visits to monitor for epileptic seizures and other outcomes. The trial also examines brain activity through electroencephalogram analyses, genetic markers, and various neuropsychological functions. During the study, participants will undergo multiple assessments including EEG tests at set intervals, neuropsychological evaluations at 6 and 24 months, and quality of life questionnaires. Researchers will track seizure development, side effects of biperiden, and health status over two years. This long-term monitoring helps determine the drug's safety and effects on epilepsy prevention after brain injury.
CONDITIONS
Brief Title
Biperiden Trial for Epilepsy Prevention
Who Can Participate
Age: 18Years - 75Years
All Genders
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 3 to 5 if sedated at the accident scene with previous GCS between 6 and 15
- 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
- History of seizures or use of antiepileptic medication
- Pregnancy
- Participation in another clinical trial at time of randomization
- History of neoplasia, neurodegenerative diseases, stroke, cognitive impairment
- History of benign prostatic hyperplasia, atrioventricular block, cardiac arrhythmia, glaucoma, megacolon, or mechanical obstruction
- Homeless patients
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 10 days
Participants receive biperiden or placebo intravenously every 6 hours for 10 consecutive days after traumatic brain injury.
Daily visits for 10 days (in-person)
Follow-up
Duration - Up to 24 months
Participants are followed for up to 2 years to assess the development of epileptic seizures and other health outcomes.
Periodic visits at 1, 3, 6, 9, 12, 18, and 24 months (in-person)
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
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Research Team
E
Eliana Garzon, MD, PhD
M
Maira L Foresti, PhD
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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Published Research Related To This Trial
A population-based study of seizures after traumatic brain injuries.
J F Annegers, W A Hauser, S P Coan...
https://pubmed.ncbi.nlm.nih.gov/9414327Modelling traumatic brain injury and posttraumatic epilepsy in rodents.
Rhys D Brady, Pablo M Casillas-Espinosa, Denes V Agoston...
https://pubmed.ncbi.nlm.nih.gov/30121231Modification of the natural progression of epileptogenesis by means of biperiden in the pilocarpine model of epilepsy.
Simone Bittencourt, Enéas Ferrazoli, Maria Fernanda Valente...
https://pubmed.ncbi.nlm.nih.gov/29096134Epilepsy after head injury.
Raimondo D'Ambrosio, Emilio Perucca
https://pubmed.ncbi.nlm.nih.gov/15542983Controversies in posttraumatic epilepsy.
A M da Silva, A R Vaz, I Ribeiro...
https://pubmed.ncbi.nlm.nih.gov/2129092Traumatic Brain Injury Epidemiology in Brazil.
Carlos Eduardo Romeu de Almeida, José Lopes de Sousa Filho, Jules Carlos Dourado...
https://pubmed.ncbi.nlm.nih.gov/26485419Catalogue of bias: publication bias.
Nicholas J DeVito, Ben Goldacre
https://pubmed.ncbi.nlm.nih.gov/30523135Analyzing risk factors for late posttraumatic seizures: a prospective, multicenter investigation.
Jeffrey Englander, Tamara Bushnik, Thao T Duong...
https://pubmed.ncbi.nlm.nih.gov/12638104Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.
Don Husereau, Michael Drummond, Stavros Petrou...
https://pubmed.ncbi.nlm.nih.gov/23538200