Biperiden Trial for Epilepsy Prevention

• Status: Not yet recruiting
• Trial end date: 2026-12-20
• Target enrollment: 0
• Participant gender: All

Summary

One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE. In previous studies with animals models of epilepsy, the biperiden decreased the incidence and intensity of spontaneous epileptic seizures besides delaying their appearance. The aim of this study is the evaluation of biperiden as antiepileptogenic drug to prevent PTE and also the determination of side effects, evaluating its cost-effectiveness in patients with moderate and severe TBI.

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

Details

• Lead Sponsor: Hospital Sirio-Libanes
• Collaborators: Ministry of Health, Brazil; PROADI-SUS
• Treatments: Biperiden

Criteria

Inclusion Criteria:

• Given informed consent

• 18 - 75 years of age

• Glasgow scale higher than 6 and smaller than 12 at the trauma scene

• moderate or severe acute traumatic brain injury

• all genders

• brain CT scan with signs of acute intraparenchymatous contusion

Exclusion Criteria:

• Previous use of biperiden

• history of epilepsy (confirmed by patient chart)

• History of seizures or use of antiepileptic medication

• family history of epilepsy

• pregnancy

• participation in another clinical trial at the time of randomization

• History of neoplasia, neurodegenerative diseases; history of stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or any other cardiac arrhythmia, or glaucoma;