NCT01048138

Use of Biperiden for the Prevention of Post-traumatic Epilepsy

Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment with biperiden should be initiated in the first 12 hours after trauma as means to avoid the epileptogenic process. The treatment will be repeated every 6 hours for 10 consecutive days. The efficacy of biperiden as an antiepileptogenic drug will be established by analyzing the development of PTE between the biperiden and placebo groups. Several patients' aspects (clinical, electroencephalography, brain imaging, genetic and behavioral data) will be monitored for two year follow-up to unravel the mechanisms by which biperiden exerts its actions on epileptogenesis. The investigators are already at the early stages of patient's recruitment using the available resources.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Biperiden Lactate	5mg IV(in the vein)every 6 hours for 10 days
DRUG	Placebo	5mg IV(in the vein)every 6 hours for 10 days

Timeline

• Start date: 2018-01-31
• Primary completion: 2022-12-02
• Completion: 2022-12-02
• First posted: 2010-01-13
• Last updated: 2023-01-31

Locations

1 site across 1 country: Brazil