Not Yet RecruitingPhase 2/3

Valproic AcId for Traumatic BRAin INjury Trial

United States432 participantsStarted 2026-05

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female between the ages of 18 and 65 years.
✓. Body Mass Index between 18 kg/m2 and 35 kg/m2.
✓. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
✓. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.
✓. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria

Exclusion criteria

✕. Persons with known history of adverse reactions to VPA
✕. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.
✕. Persons with a known history of thrombocytopenia.
✕. Persons with platelet count less than 100,000 per microliter of blood.
✕. Persons with 2nd or 3rd degree burns of any size and location.
✕. Female subjects who are pregnant or lactating.
✕. Persons who are currently incarcerated or are in police custody.
✕. Persons with inadequate venous access.

What they're measuring

Extended Glasgow Outcome Scale (GOS-E)

Timeframe: 3 months post-injury

Trial details

NCT IDNCT07166393

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-02

Contact for this trial

Hasan Alam, MD

312-926-4962 Hasan.Alam@nm.org

View on ClinicalTrials.gov More Moderate Traumatic Brain Injury (TBI) trials