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Could common drugs help heal traumatic brain injuries? new trial aims to find out

NCT ID NCT05826912

Disease control Sponsor: University of California, San Francisco 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether certain FDA-approved drugs, used off-label, can help people recover better after a traumatic brain injury (TBI). About 672 adults with moderate to severe TBI will receive either an experimental drug or a placebo within 24 hours of their injury. The main goal is to see if the drugs improve functional recovery, measured by the Glasgow Outcome Scale, over three months.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 672 people

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

Started

Aug 2024

Expected to finish

Aug 2029

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. Adults (18-65 years of age, inclusive) 2. Presents to a participating enrollment site and is able to receive first dose within 24 hours of non-penetrating head injury warranting clinical evaluation with a non-contrast head CT based on American College of Emergency Physicians (ACEP) Centers for Disease Control and Prevention (CDC) clinical policy for TBI imaging. 3. Closest, prior to Randomization Glasgow Coma Scale (GCS) score of 9 to 15 4. Acute trauma-related neuroimaging abnormality (subarachnoid hemorrhage, contusion, subdural hematoma, petechial hemorrhage, intraventricular hemorrhage) on cranial CT (CT+) 5. Initial Glial Fibrillary Acidic Protein (GFAP) blood level \>100 pg/ml ≤ 15,000 pg/ml determined using a for Research Use Only (RUO) assay(s) or an Investigation Use Only (IUO) assay(s) 6. Persons of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods for the duration of investigational product administration (see manual of procedures for adequate birth control methods) 7. Participants able to undergo Magnetic Resonance Imaging (MRI) scans, no contraindications 8. Participants or legally authorized representative (LAR) willing and able to provide informed consent 9. Participants or LAR able to read, speak, and understand English or Spanish (participating site dependent, where available), including the informed consent form (ICF) 10. Willingness and ability to comply with all study procedures, treatment, and follow-up Exclusion Criteria: 1. Isolated epidural hematoma 2. Pre-existing conditions including disabling developmental, neurologic, psychiatric, medical disorder that continues to produce functional disability up to the time of injury; or imminent death based on clinical judgement 3. Current enrollment in another interventional study 4. Currently pregnant or currently breastfeeding or planning on becoming pregnant in the next 6 months 5. Current incarceration or in custody 6. Currently prescribed one of the investigational products (or other drugs in the same class) prior to injury; or contra-indicated or as listed in the appendices 7. Hypersensitivity or intolerance to investigational products or the investigational products' respective classes 8. Renal dysfunction (Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (eGFR) (\<60 mL/minute/1.73 m2) 9. Acute liver disease or hepatic dysfunction (ALT/AST \>3 times upper limit of normal lab value) 10. Hemodynamic instability, per participating site physician investigator clinical judgment 11. Inability to swallow investigational product capsule 12. Unable or unwilling to consume animal byproducts, has a gelatin allergy, and/or religious beliefs that do not permit consuming gelatin 13. Intolerance to small amounts of lactose (less than ½ teaspoonful) daily 14. Low likelihood of follow up or study compliance, or any other reason, in the opinion of the participating site investigator, the participants should not participate in the study

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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.

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

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Atrium Health Wake Forest Baptist

    Charlotte, North Carolina, 28203, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • The University of Texas at Austin

    Austin, Texas, 78712, United States

  • UTHealth Houston

    Houston, Texas, 77030, United States

  • UW Health University Hospital

    Madison, Wisconsin, 53792, United States

  • University of California, San Francisco

    San Francisco, California, 94110, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Washington

    Seattle, Washington, 98104, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

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