Study of Biperiden to Prevent Epilepsy After Moderate or Severe Traumatic Brain Injury in Adults Aged 18 to 75

What this Trial Is About

Researchers are studying biperiden as a potential preventive treatment for post traumatic epilepsy PTE, a common neurological complication after moderate or severe traumatic brain injury TBI. This research aims to evaluate if biperiden can reduce the occurrence of PTE, assess its side effects, and analyze its cost-effectiveness. The trial focuses on adult patients with moderate or severe TBI, as PTE often develops within two years after injury and currently lacks effective prevention. Participants are randomly assigned to receive either 5 mg of biperiden intravenously every 6 hours for 10 days or a placebo with similar administration. The treatment starts within 18 hours of brain injury. The study includes a two-year follow-up period with regular visits to monitor for epileptic seizures and other outcomes. The trial also examines brain activity through electroencephalogram analyses, genetic markers, and various neuropsychological functions. During the study, participants will undergo multiple assessments including EEG tests at set intervals, neuropsychological evaluations at 6 and 24 months, and quality of life questionnaires. Researchers will track seizure development, side effects of biperiden, and health status over two years. This long-term monitoring helps determine the drugs safety and effects on epilepsy prevention after brain injury.

Biperiden Trial for Epilepsy Prevention