drugset / Trial / NCT01048138

Use of Biperiden for the Prevention of Post-traumatic Epilepsy

NCT01048138 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-01-31
Primary completion
2022-12-02
Completion
2022-12-02

Outcome

Missed primary endpoint

Stopped (Enrollment): “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.”

paper Data analysis indicated lack of evidence of biperiden for either, the incidence of post-traumatic epilepsy (2.6, 95%CI, 0.65-10.57; p = 0.170) PMID 39175759 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Biperiden Small molecule 5 mg Intravenous