Biperiden Trial for Epilepsy Prevention
Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury
Hospital Sirio-Libanes
312 participants
Jan 10, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Given informed consent
- - 75 years of age
- GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene with previous GCS between 6 and 15.
- Moderate or severe acute traumatic brain injury
- All genders
- Brain CT scan with signs of of acute intraparenchymal hemorrhage and/or contusion
- Able to receive the first dose of treatment or placebo within 18 hours of brain injury,
Exclusion Criteria7
- Previous use of biperiden
- History of epilepsy (confirmed by patient chart)
- History of seizures or use of antiepileptic medication
- 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 megacolon or mechanical obstruction
- Homeless patient
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Interventions
5mg of biperiden diluted in 100 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV
1ml sterile vehicle (sodium lactate, lactic acid, sodium hydroxide and water for injections) diluted in 100 ml 0.9% saline - every 6 hours for 10 consecutive days - IV
Locations(10)
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NCT04945213