Using Biperiden to Prevent Epilepsy After Brain Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of biperiden, an anticholinergic medication, in preventing post-traumatic epilepsy (PTE) in adults with moderate to severe traumatic brain injury (TBI). The study aims to determine the incidence and intensity of spontaneous seizures following TBI and assess the safety and cost-effectiveness of biperiden compared to a placebo. Participants will be monitored for side effects and overall outcomes to establish biperiden's potential as a preventive treatment for PTE.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Given informed consent
* 18 - 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 Criteria:

* 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

Where it's running

• Santa Casa de Misericórdia de Sobral
  Sobral, Ceará, Brazil Recruiting
• Hospital São Rafael
  Salvador, Estado de Bahia, Brazil Recruiting
• Associação Beneficente Santa Casa de Campo Grande
  Campo Grande, Mato Grosso do Sul, Brazil Recruiting
• Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão Preto
  Ribeirão Preto, São Paulo, Brazil Recruiting
• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  São Paulo, São Paulo, Brazil Recruiting
• Hospital Sirio-Libanes
  São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Luiz E Mello, MD, PhD — Hospital Sirio-Libanês
• Study coordinator: Eliana Garzon, MD, PhD
• Email: eliana.garzon@hsl.org.br
• Phone: +55 (11) 98206-2308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding brain function and cognitive outcomes after traumatic brain injury

  This study is trying to see how blood flow and brain health after a serious head injury affect thinking and memory recovery one year later for those who have had a moderate to severe traumatic brain injury.

  Recruiting at 3 sites University of Texas Southwestern Medical Center · Dallas, Texas and 2 other locations · NCT06480838

• Comparing two group wellness programs for people with brain injuries and their caregivers

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  Recruiting Kessler Foundation · East Hanover, New Jersey · NCT05048966

• Online memory intervention for people with traumatic brain injury

  This study tests whether an online memory training program can help people with moderate to severe traumatic brain injury improve their memory and brain health.

  Recruiting Toronto Rehabilitation Institute · Toronto, Ontario · NCT04331392

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.