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Could a single dose of valproic acid help heal the brain after injury?

NCT ID NCT07166393

Disease control Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests whether a single dose of valproic acid, given soon after a moderate to severe traumatic brain injury, can improve patients' recovery and reduce disability. About 432 adults aged 18 to 65 will be randomly assigned to receive either valproic acid (at a low or high dose) or a placebo, alongside standard care. The main goal is to see if the drug leads to better outcomes on a scale that measures recovery from death to full independence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
valproic acid
What this could lead to
If it works, this could point toward a simple, one-dose treatment to improve recovery and reduce disability after a traumatic brain injury.
What could go wrong
This is an early-to-mid stage trial, so the drug may not prove effective. Valproic acid also has known side effects, including liver problems and bleeding risk, which could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 432 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2027

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female between the ages of 18 and 65 years. 2. Body Mass Index between 18 kg/m2 and 35 kg/m2. 3. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test. 4. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12. 5. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3) criteria Exclusion Criteria: 1. Persons with known history of adverse reactions to VPA 2. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency. 3. Persons with a known history of thrombocytopenia. 4. Persons with platelet count less than 100,000 per microliter of blood. 5. Persons with 2nd or 3rd degree burns of any size and location. 6. Female subjects who are pregnant or lactating. 7. Persons who are currently incarcerated or are in police custody. 8. Persons with inadequate venous access. 9. Treatment cannot start within 120 minutes from the onset of injury 10. Non-survivable injuries in the estimation of the attending trauma surgeon. 11. Interfacility transfers 12. The time of injury is unknown 13. Patients in hemorrhagic shock with a systolic blood pressure of \<90 mmHg on initial evaluation. 14. Persons with a known "do not resuscitate" order prior to randomization 15. Persons with a research "opt out" bracelet 16. Persons who are currently enrolled in another clinical trial. 17. Greater than 90 minutes between the onset of injury and arrival to the hospital

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate traumatic brain injury (TBI) Severe traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Arizona

    Tucson, Arizona, 85719-4824, United States

  • University of California, Davis

    Sacramento, California, 95817, United States

  • University of Southern California

    Los Angeles, California, 90089-0701, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.