Clinical Trial: Use of Biperiden for the Prevention of Post-traumatic Epilepsy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study
Brief 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 Summary:
Sponsor: Federal University of São Paulo
Current Primary Outcome: Onset of post-traumatic epilepsy [ Time Frame: 12 months after hospital discharge ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Onset of post-traumatic epilepsy [ Time Frame: 24 months after hospital discharge ]
- Quality of Life [ Time Frame: Measured at 12 and 24 month after hospital discharge ]
- Cognitive level [ Time Frame: Measured at 12 and 24 month after hospital discharge ]
Original Secondary Outcome: Same as current
Information By: Federal University of São Paulo
Dates:
Date Received: January 12, 2010
Date Started: March 2014
Date Completion: September 2018
Last Updated: April 15, 2014
Last Verified: April 2014
