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Valproic AcId for Traumatic BRAin INjury Trial

Study acronym: VIBRANT
StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Feb 2030 → May 2031
See other at-risk trials from Northwestern University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 2030 to May 2031
    • Start date: May 2026 to May 2027
    • Study completion pushed from Dec 2030 to Dec 2031
    • Eligibility criteria expanded, about 1 word
    v3
  2. Primary endpoint revised
    • Secondary endpoints revised (2)
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI). Patients with moderate to severe TBI will randomly receive either: 1. Standard of care treatment and normal saline 2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose
Trial Details
NCT Number NCT07166393
Lead Sponsor Northwestern University
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
Related terms Brain Injuries, Traumatic
Enrollment 432 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov