Biperiden Trial for Epilepsy Prevention

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHospital Sirio-Libanes

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

312 Participants
are divided into 2 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