TerminatedPhase 3

Use of Biperiden for the Prevention of Post-traumatic Epilepsy

Stopped: Recruitment and funding issues, together with the event of the SARS-CoV-2 pandemic prompted an adjustment in the study design to stop enrollment at 123 patients.

Brazil123 participantsStarted 2018-01-31

Plain-language summary

There is no AED or medication that has been demonstrated to affect the development of post-traumatic epilepsy. Biperiden is a cholinergic antagonist, acting in the muscarinic receptor, that is widely used as an anti Parkinson drug. The investigators data with animal models of epilepsy indicate that anti-muscarinic agents might affect the natural course of the disease in the case of post-traumatic epilepsy.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * between 18 and 75 year of age * patients with a diagnosis of acute TBI admitted to an emergency unit within 12 hours of the accident, regardless of the accident * brain CT scan with signs of acute intraparenchymatous contusion * signed informed consent (possibly by a relative) Exclusion Criteria: * malignant neoplasia and other severe comorbidities * neurodegenerative disorders * previous cerebrovascular accident * record of convulsive seizures or use of anti-epileptic medication * pregnancy * concomitant use of the other anticholinergic medications * presence of any factor that may contraindicate the use of biperiden * participation in other clinical trial * alcohol intoxication will not lead to exclusion of the subject.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Outcome: Indidence of post-traumatic epilepsy

Timeframe: 24 months after TBI

Trial details

NCT IDNCT01048138

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-02

View on ClinicalTrials.gov More Traumatic Brain Injury trials