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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
5mg IV(in the vein)every 6 hours for 10 days
5mg IV(in the vein)every 6 hours for 10 days
Federal University of São Paulo
São Paulo, Brazil
Clinical Outcome: Indidence of post-traumatic epilepsy
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.
Time frame: 24 months after TBI
Frequency of seizures
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.
Time frame: 24 months after TBI
Mortality and adverse effects
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.
Time frame: 24 months after TBI
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