Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury
NCT ID: NCT05826912
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
672 participants
INTERVENTIONAL
2024-08-01
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention 1: Atorvastatin calcium (ATOR)
By Mouth (PO) Twice a day (BID) 80 mg/day, with no loading dose, for 28 days
Atorvastatin Calcium
Capsule, 80 mg/day, with no loading dose, for 28 days
Intervention 2: Minocycline hydrochloride (MINO)
By Mouth (PO) Twice a day (BID) 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
Minocycline Hydrochloride
Capsule, 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
Intervention 3: Candesartan cilexetil (CAND)
By Mouth (PO) Twice a day (BID) 8 mg once on Day 1, then 16 mg daily for 27 days
Candesartan Cilexetil
Capsule, 8 mg once on Day 1, then 16 mg daily for 27 days
Matching Placebo
By Mouth (PO) Twice a day (BID) 2 capsules 2x/day
Placebo
Capsule, 2x/day for 28 days
Interventions
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Atorvastatin Calcium
Capsule, 80 mg/day, with no loading dose, for 28 days
Minocycline Hydrochloride
Capsule, 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
Candesartan Cilexetil
Capsule, 8 mg once on Day 1, then 16 mg daily for 27 days
Placebo
Capsule, 2x/day for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Geoffrey Manley, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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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
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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APT-TBI-01
Identifier Type: -
Identifier Source: org_study_id