Use of Biperiden for the Prevention of Post-traumatic Epilepsy

• Status: Recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborators: Cristália Produtos Químicos Farmacêuticos Ltda.; University of Sao Paulo
• Treatments: Biperiden; Biperiden lactate

Criteria

Inclusion Criteria:

• between 18 and 75 year of age

• patients with a diagnosis of severe TBI admitted to an emergency unit within 6 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

• cerebrovascular accident in the previous 6 months

• 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.