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Valproic AcId for Traumatic BRAin INjury Trial
Sponsor: Northwestern University
Summary
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
Official title: Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
432
Start Date
2026-05
Completion Date
2030-12
Last Updated
2025-09-22
Healthy Volunteers
No
Interventions
Valproic Acid (VPA)
VPA (in 250 ml 0.9% sodium chloride solution)
Standard of care treatment + normal saline
Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)
Locations (8)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
Oregon Health & Science University
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States