Tests biperiden to prevent epilepsy after moderate or severe brain injury
Tests biperiden against placebo to prevent seizures in adults with serious head injury.
Plain-language title generated from the registry record
Registry title: Biperiden Trial for Epilepsy Prevention
Key facts
- Where
- Campo Grande, Fortaleza, Passo Fundo, Ribeirão Preto, Salvador, São Paulo, Sobral, and Vitória, BrazilSee the 10 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with a recent moderate or severe traumatic brain injury. It tests biperiden against placebo to see if it prevents epilepsy after the injury.
- Age
- 18 to 75 years
- Sex
- All genders can join.
- Disease stage
- Moderate or severe acute traumatic brain injury. Brain CT scan shows signs of acute bleeding inside the brain tissue and/or a contusion. GCS between 6 and 12 at hospital admission. GCS between 3 and 5 can join if the person was sedated at the accident scene and had a GCS between 6 and 15 before.
- Earlier treatment
- The first dose of treatment or placebo must be possible within 18 hours of the brain injury. People who used biperiden before cannot join.
Main reasons for not taking part
- Previous use of biperiden
- History of epilepsy or seizures, or use of antiepileptic medication
- Pregnancy
- Taking part in another clinical trial at the time of randomization
- History of cancer, neurodegenerative disease, stroke, cognitive impairment, enlarged prostate, heart block or other heart rhythm problem, glaucoma, megacolon or mechanical obstruction
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04945213, who can take part
Where in Brazil
- Associação Beneficente Santa Casa de Campo GrandeCampo Grande, BrazilTaking people
- Instituto Doutor José FrotaFortaleza, BrazilNot yet recruiting
- Hospital São Vicente de PauloPasso Fundo, BrazilNo longer taking part
- Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão PretoRibeirão Preto, BrazilTaking people
- Hospital Sao RafaelSalvador, BrazilTaking people
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São PauloSão Paulo, BrazilTaking people
- Hospital São Paulo, Universidade Federal de São PauloSão Paulo, BrazilNot yet recruiting
- Hospital Sirio LibanesSão Paulo, BrazilTaking people
- Santa Casa de Misericórdia de SobralSobral, BrazilTaking people
- Hospital Estadual Urgencia e Emergencia -HEUEVitória, BrazilNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Sirio-Libanes
- Trial code
- NCT04945213
- Record updated
- 26 March 2024
- Original description
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.Read full original descriptionShow less
Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury
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.
Inclusion: 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: Previous use of biperiden; 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; Pregnancy; Participation in another clinical trial at the time of randomization; Homeless patient.