Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07166393

Valproic AcId for Traumatic BRAin INjury Trial

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Moderate Traumatic Brain Injury (TBI) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Severe Traumatic Brain Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

The specific aim is to determine whether giving VPA at either a 50 mg/kg dose or a 100 mg/kg is safe (as measured by adverse events after treatment) in patients with moderate to severe TBI due to brain bruises.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Treatment cannot start within 120 minutes from the onset of injury
  • Non-survivable injuries in the estimation of the attending trauma surgeon.
  • Interfacility transfers
  • The time of injury is unknown
  • Patients in hemorrhagic shock with a systolic blood pressure of <90 mmHg on initial evaluation.
  • Persons with a known "do not resuscitate" order prior to randomization
  • Persons with a research "opt out" bracelet
  • Persons who are currently enrolled in another clinical trial.
  • Greater than 90 minutes between the onset of injury and arrival to the hospital

Treatment and study plan

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)

Primary outcomes

  1. Extended Glasgow Outcome Scale (GOS-E)

    Time frame: 3 months post-injury

    Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.

Secondary outcomes

  1. Hemorrhagic progression of the contusion (HPC)

    Time frame: First 24 hours post-injury as measured by a CT scan

    We will quantify HPC as the change in volume of the largest contiguous brain lesion in mm. This will be measured through a comparison of the initial and the follow-up CT scan.

  2. Disability Rating Score (DRS)

    Time frame: Discharge or day 7 and 3 months post-injury

    This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.

Other outcomes

  1. Disability Rating Score (DRS)

    Time frame: 6 months post-injury

    This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.

  2. Extended Glasgow Outcome Scale (GOS-E)

    Time frame: 6 months post injury

    Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.

  3. Glasgow Coma Scale (GCS)

    Time frame: 24 hours post-injury

    Evaluates three behavior responses: eye opening, best verbal and best motor. The following scoring is associated with responses: Eye opening response - Spontaneously 4, To speech 3, To pain 2 and No response 1; Best verbal - Oriented to time/place/person 5, Confused 4, Inappropriate words 3, Incomprehensible sounds 2 and No response 1; and Best motor response - Obeys commands 6, Moves to localized pain 5, Flexion withdrawal from pain 4, Abnormal flexion 3, Abnormal extension 2 and No response 1. The scoring is totaled with higher values associated with better response. Total Score: Best response=15, Comatose client=8 or less, and Totally unresponsive=3.

Study contacts

Contact information is provided by the study sponsor or research team.

Hasan Alam, MD

CONTACT

[email protected]

312-926-4962

Nicole Meredyth, MD

CONTACT

[email protected]

312-694-4867

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Multi-institutional Phase 2/3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury

Acronym: VIBRANT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 10, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.