Use of Biperiden for the Prevention of Post-traumatic Epilepsy

Phase 3

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Biperiden Lactate; Drug: Placebo

• Registration Number: NCT01048138
• Lead Sponsor: Federal University of São Paulo

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 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.

Study Timeline

• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Study Start: 2018-01-31
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-02
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• between 18 and 75 year of age
• patients with a diagnosis of acute TBI admitted to an emergency unit within 12 hours of the accident, regardless of the accident
• brain CT scan with signs of acute intraparenchymatous contusion
• signed informed consent (possibly by a relative)

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Exclusion Criteria

• malignant neoplasia and other severe comorbidities
• neurodegenerative disorders
• previous cerebrovascular accident
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biperiden Lactate	Biperiden Lactate	5mg IV(in the vein)every 6 hours for 10 days
Placebo	Placebo	5mg IV(in the vein)every 6 hours for 10 days

Primary Outcome Measures

Name	Time	Method
Clinical Outcome: Indidence of post-traumatic epilepsy	24 months after TBI	The incidence of seizures will be evaluated starting immediately after TBI and continuously during the hospitalization period and after hospital discharge during the two year follow up period. Patients and their relatives will be asked to maintain a diary of seizures, and thus record all seizures with detailed descriptions of each event. The recordings will be evaluated in each patient visit. Seizures incidence will be compared between placebo and biperiden-treated patients.

Secondary Outcome Measures

Name	Time	Method
Frequency of seizures	24 months after TBI	The frequency of seizures will be counted starting immediately after TBI and continuously during the hospitalization period and after hospital discharge during the two year follow up period. Frequency of seizure will be compared between placebo and biperiden-treated patients.
Mortality and adverse effects	24 months after TBI	The incidence of death and adverse effects will be counted starting immediately after TBI and continuously during the hospitalization period and after hospital discharge during the two year follow up period. Incidence of death and adverse effects will be compared between placebo and biperiden-treated patients.

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 Sao Paulo, Brazil