Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury

Enrolling by invitation · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

The purpose of this study is to determine if experimental drug treatment improves recovery after TBI as compared to a control (placebo) group. Changes in recovery will be measured throughout the study. The study drugs listed below are approved by the U.S. Food and Drug Administration (FDA) but are being used "off-label" in this study. This means that the drugs are not currently approved to treat TBI.

Key facts

Study ID

NCT05826912

Run by

University of California, San Francisco

People needed

672

Starts

2024-08-01

Expected to finish

2029-08-31

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (18-65 years of age, inclusive)
• 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.
• Closest, prior to Randomization Glasgow Coma Scale (GCS) score of 9 to 15
• Acute trauma-related neuroimaging abnormality (subarachnoid hemorrhage, contusion, subdural hematoma, petechial hemorrhage, intraventricular hemorrhage) on cranial CT (CT+)
• 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)
• 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)
• Participants able to undergo Magnetic Resonance Imaging (MRI) scans, no contraindications
• Participants or legally authorized representative (LAR) willing and able to provide informed consent
• Participants or LAR able to read, speak, and understand English or Spanish (participating site dependent, where available), including the informed consent form (ICF)
• Willingness and ability to comply with all study procedures, treatment, and follow-up

You may not qualify if…

• Isolated epidural hematoma
• 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
• Current enrollment in another interventional study
• Currently pregnant or currently breastfeeding or planning on becoming pregnant in the next 6 months
• Current incarceration or in custody
• 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
• Hypersensitivity or intolerance to investigational products or the investigational products' respective classes
• Renal dysfunction (Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (eGFR) (<60 mL/minute/1.73 m2)
• Acute liver disease or hepatic dysfunction (ALT/AST >3 times upper limit of normal lab value)
• Hemodynamic instability, per participating site physician investigator clinical judgment
• Inability to swallow investigational product capsule
• Unable or unwilling to consume animal byproducts, has a gelatin allergy, and/or religious beliefs that do not permit consuming gelatin
• Intolerance to small amounts of lactose (less than ½ teaspoonful) daily
• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Indiana University Health — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Atrium Health Wake Forest Baptist — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas at Austin — Austin, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• UTHealth Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States
• UW Health University Hospital — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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