NCT04945213RecruitingPhase 3
Biperiden Trial for Epilepsy Prevention
Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury
Source: ClinicalTrials.gov · Last updated 26 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 25 Jun 2021
- Start date
- 10 Jan 2023
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- Hospital Sirio-Libanes
- Diseases
- Epilepsy
- NCT number
- NCT04945213
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 312
- From 10 Jan 2023 to the primary completion date, 20 Dec 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous use of biperiden
Other illness
- History of epilepsy (confirmed by patient chart)
- History of seizures or use of antiepileptic medication
- 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
Other
- Pregnancy
- Participation in another clinical trial at the time of randomization
- Homeless patient
Who the study is looking for
- 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,
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Associação Beneficente Santa Casa de Campo Grande Coordinator of this site? Confirm its status | Campo Grande | Brazil | Recruiting |
| Instituto Doutor José Frota Coordinator of this site? Confirm its status | Fortaleza | Brazil | Not yet recruiting |
| Hospital São Vicente de Paulo Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Active, not recruiting |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| Hospital Sao Rafael Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital Sirio Libanes Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital São Paulo, Universidade Federal de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Santa Casa de Misericórdia de Sobral Coordinator of this site? Confirm its status | Sobral | Brazil | Recruiting |
| Hospital Estadual Urgencia e Emergencia -HEUE Coordinator of this site? Confirm its status | Vitória | Brazil | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.