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 range18 Years – 75 Years

SexALL

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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.

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

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