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Biperiden Trial for Epilepsy Prevention

Study acronym: BIPERIDEN
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 1 to 10v7
  2. Eligibility criteria revised
    • Collaborators: 6 to 9
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 7 more changesShow less
    • Start date changed from estimate of Feb 1, 2022 to Jan 10, 2023
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: 5 to 12
    • Study description expanded, about 11 words
    • Site details revised
    • Collaborators: 2 to 6
  5. Primary and study completion dates: Dec 20, 2025 to Dec 20, 2026
    • Start date: Sep 1, 2021 to Feb 1, 2022
    v3
  6. Start date: Aug 1, 2021 to Sep 1, 2021v2 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Secondary endpoints revised (5)
    • Study description shortened, about 21 words
    • Publications: 14 to 15
    • Eligibility criteria expanded, about 1 word
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04945213
Lead Sponsor Hospital Sirio-Libanes
Collaborators: PROADI-SUS, Ministry of Health, Brazil, University of Sao Paulo, Santa Casa de Campo Grande, Hospital Sao Rafael, Santa Casa de Misericórdia de Sobral, Hospital São Paulo, Universidade Federal de São Paulo, Instituto Doutor José Frota, Hospital São Vicente de Paulo
Conditions
(from sponsor)		 Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Post Traumatic Epilepsy
Related terms Brain Injuries, Epilepsy, Epilepsy, Post-Traumatic
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov