Valproic AcId for Traumatic BRAin INjury Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Northwestern University
Study ID
NCT07166393
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Moderate Traumatic Brain Injury (TBI)
  • Severe Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Valproic Acid (VPA) — DRUG
    VPA (in 250 ml 0.9% sodium chloride solution)
  • Standard of care treatment + normal saline — OTHER
    Standard of care treatment + normal saline (0.9% sodium chloride solution) vehicle (250 ml)

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
Sep 2025
Primary completion
Feb 28, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
432 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control
    Standard of Care + Normal Saline (0.9% sodium chloride solution)
  • Experimental: Experimental
    Standard of care treatment + one dose of VPA (in 250 ml 0.9% sodium chloride solution) in the following two doses: * Lower dose VPA: 50 mg/kg * Higher dose VPA: 100 mg/kg

Primary Outcome Measure

Extended Glasgow Outcome Scale (GOS-E) [ Time Frame: 3 months post-injury ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Joel Rodgers
[email protected]
205-515-3590
Jan Jansen, MD (PRINCIPAL_INVESTIGATOR)
University of ArizonaTucsonArizona85719-4824
Robin Carlson, PhD
[email protected]
520-626-2876
Joseph Bellal, MD (PRINCIPAL_INVESTIGATOR)
University of Southern CaliforniaLos AngelesCalifornia90089-0701
Monica Wong
[email protected]
323-409-8597
Matthew Martin, MD (PRINCIPAL_INVESTIGATOR)
Kenji Inaba, MD (SUB_INVESTIGATOR)
University of California, DavisSacramentoCalifornia95817
Shari Nichols
[email protected]
Rachael Callcut, MD (PRINCIPAL_INVESTIGATOR)
Rachel Russo, MD (SUB_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Samanatha Underwood
[email protected]
503-494-5400
Mitchell Sally, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Heather White
[email protected]
615-421-2996
Amelia Maiga, MD (PRINCIPAL_INVESTIGATOR)
Mayur Patel, MD (SUB_INVESTIGATOR)
University of Texas SouthwesternDallasTexas75390
Katherine Bosler
[email protected]
Linda Dultz, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Madison Rundell, BS
[email protected]
Marc de Moya, MD (PRINCIPAL_INVESTIGATOR)

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University of Alabama at Birmingham· Birmingham, ALUniversity of Arizona· Tucson, AZUniversity of Southern California· Los Angeles, CAUniversity of California, Davis· Sacramento, CAOregon Health & Science University· Portland, ORVanderbilt University Medical Center· Nashville, TN

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