MedTrace Logo

Biperiden Trial for Epilepsy Prevention

NCT04945213 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2024-03-26

No results posted yet for this study

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.

Conditions

  • Brain Injury Traumatic Moderate
  • Brain Injury Traumatic Severe
  • Post Traumatic Epilepsy

Interventions

DRUG

Biperiden

5mg of biperiden diluted in 100 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV

OTHER

Placebo

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

Sponsors & Collaborators

  • PROADI-SUS

    collaborator UNKNOWN

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • University of Sao Paulo

    collaborator OTHER

  • Santa Casa de Campo Grande

    collaborator OTHER

  • Hospital Sao Rafael

    collaborator OTHER

  • Santa Casa de Misericórdia de Sobral

    collaborator UNKNOWN

  • Hospital de Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    collaborator UNKNOWN

  • Hospital São Paulo, Universidade Federal de São Paulo

    collaborator UNKNOWN

  • Instituto Doutor José Frota

    collaborator UNKNOWN

  • Hospital São Vicente de Paulo

    collaborator UNKNOWN

  • Hospital Sirio-Libanes

    lead OTHER

Principal Investigators

  • Luiz E Mello, MD, PhD · Hospital Sirio-Libanês

  • Eliana Garzon, MD, PhD · Hospital Sirio-Libanês

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2026-12-20
Completion
2026-12-20

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04945213 on ClinicalTrials.gov