Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Geoffrey Manley, MD PhD
Headshot of Geoffrey Manley
Geoffrey Manley

Description

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.

Keywords

Traumatic Brain Injury, Brain Injuries, Traumatic Brain Injuries, Wounds and Injuries, Minocycline, Candesartan, Candesartan cilexetil, Atorvastatin, Calcium, Atorvastatin Calcium, Minocycline Hydrochloride

Eligibility

You can join if…

Open to people ages 18-65

  1. Adults (18-65 years of age inclusive)
  2. Presents to an enrollment site within 12 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. Post-resuscitation Glasgow Coma Scale (GCS) of between 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 the participant is 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 or need for sedation
  8. Participants/legally authorized representative (LAR) willing and able to provide informed consent
  9. Participants or legally authorized representative able to read, speak, understand English or Spanish including the informed consent form (ICF)

    10. Willingness and ability to comply with all study procedures, treatment and follow-up 11. Participants identified by site investigator as a good candidate for study

    participation

You CAN'T join if...

  1. Post-resuscitation GCS <9
  2. Isolated epidural hematoma
  3. 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
  4. Current enrollment in another interventional study
  5. Currently pregnant or currently breastfeeding or planning on becoming pregnant in the next 6 months
  6. Current incarceration
  7. 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
  8. Hypersensitivity or intolerance to investigational products or the investigational products respective classes
  9. Renal dysfunction (Creatinine Clearance (CrCl) or Estimate Glomerular Filtration Rate (eGFR) <60 mL/minute/1.73 m2)

    10. Hepatic dysfunction (Alanine Transaminase (ALT)/Aspartate Transaminase (AST)) >3 times

    upper limit of normal lab value)

    11. Persistent hypotension, more than 30 minutes (Systolic Blood Pressure (SBP) <90 mmHg

    and Diastolic Blood Pressure (DBP) <60 mmHg)

    12. Inability to swallow investigational product capsule 13. Low likelihood of follow up or study compliance, or any other reason, in the opinion

    of the site investigator, the participants should not participate in the study

Location

  • UCSF
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Geoffrey Manley, MD PhD
    Dr. Manley is Chief of Neurosurgery at Zuckerberg San Francisco General Hospital and Professor and Vice Chairman of Neurological Surgery at UCSF. He is a trauma neurosurgeon and Co-Director of the Brain and Spinal Injury Center. Dr. Manley's research interests range from molecular aspects of traumatic brain injury (TBI) to the clinical care of TBI victims.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Related Info Related Info #2 Related Info #3
ID
NCT05826912
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 672 study participants
Last Updated