By InvitationPhase 2

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

United States672 participantsStarted 2024-08-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Change in Glasgow Outcome Scale-Extended (GOSE 2-Way)

Timeframe: 2 weeks to 3 months postinjury

Trial details

NCT IDNCT05826912

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-31

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