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NOT YET RECRUITING
NCT07166393
PHASE2/PHASE3

Valproic AcId for Traumatic BRAin INjury Trial

Sponsor: Northwestern University

View on ClinicalTrials.gov

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

DRUG

Valproic Acid (VPA)

VPA (in 250 ml 0.9% sodium chloride solution)

OTHER

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