Use of Biperiden for the Prevention of Post-traumatic Epilepsy

Federal University of São Paulo

Status and phase: Terminated; Phase 3

Conditions: Traumatic Brain Injury

Treatments: Drug: Placebo; Drug: Biperiden Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT01048138

CEP0560/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups, including a placebo group

Biperiden Lactate

Experimental group

Description:

5mg IV(in the vein)every 6 hours for 10 days

Treatment:

Drug: Biperiden Lactate

Placebo

Placebo Comparator group

Description:

5mg IV(in the vein)every 6 hours for 10 days

Treatment:

Drug: Placebo