About this trial
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 criteria
Qualifiers
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
Disqualifiers
Previous use of biperiden
History of epilepsy (confirmed by patient chart)
History of seizures or use of antiepileptic medication
Pregnancy
Trial design
Treatments tested in this trial
- Biperiden
- Placebo
Treatment groups
Sponsors and collaborators
Hospital Sirio-Libanes
Lead sponsor
PROADI-SUS
Collaborator
Ministry of Health, Brazil
Collaborator
University of Sao Paulo
Collaborator
Santa Casa de Campo Grande
Collaborator
Hospital Sao Rafael
Collaborator
Santa Casa de Misericórdia de Sobral
Collaborator
Hospital São Paulo, Universidade Federal de São Paulo
Collaborator
Instituto Doutor José Frota
Collaborator
Hospital São Vicente de Paulo
Collaborator