Using Biperiden to Prevent Epilepsy After Brain Injury
Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury
This study tests if the medication biperiden can help prevent seizures in adults who have had a serious brain injury.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital Sirio-Libanes Academic / other |
| Locations | 10 sites (Fortaleza, Ceará and 9 other locations) |
| Trial ID | NCT04945213 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of biperiden, an anticholinergic medication, in preventing post-traumatic epilepsy (PTE) in adults with moderate to severe traumatic brain injury (TBI). The study aims to determine the incidence and intensity of spontaneous seizures following TBI and assess the safety and cost-effectiveness of biperiden compared to a placebo. Participants will be monitored for side effects and overall outcomes to establish biperiden's potential as a preventive treatment for PTE.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with moderate to severe acute traumatic brain injury and specific neurological assessments.
Not a fit: Patients with a history of epilepsy or seizures, or those who have previously used biperiden, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the occurrence of epilepsy in patients recovering from traumatic brain injuries.
How similar studies have performed: Previous studies in animal models have shown promising results for biperiden in reducing seizure incidence, but this approach is novel in human subjects.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fortaleza, Ceará and 9 other locations
- Instituto Doutor José Frota — Fortaleza, Ceará, Brazil (Not_yet_recruiting)
- Santa Casa de Misericórdia de Sobral — Sobral, Ceará, Brazil (Recruiting)
- Hospital Estadual Urgencia e Emergencia -HEUE — Vitória, Espírito Santo, Brazil (Not_yet_recruiting)
- Hospital São Rafael — Salvador, Estado de Bahia, Brazil (Recruiting)
- Associação Beneficente Santa Casa de Campo Grande — Campo Grande, Mato Grosso do Sul, Brazil (Recruiting)
- Hospital São Vicente de Paulo — Passo Fundo, Rio Grande do Sul, Brazil (Active_not_recruiting)
- Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão Preto — Ribeirão Preto, São Paulo, Brazil (Recruiting)
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
- Hospital Sirio-Libanes — São Paulo, Brazil (Recruiting)
- Hospital São Paulo, Universidade Federal de São Paulo — São Paulo, Brazil (Not_yet_recruiting)
Study contacts
- Principal investigator: Luiz E Mello, MD, PhD — Hospital Sirio-Libanês
- Study coordinator: Eliana Garzon, MD, PhD
- Email: eliana.garzon@hsl.org.br
- Phone: +55 (11) 98206-2308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.