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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05826912
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Atorvastatin Calcium — DRUG
    Capsule, 80 mg/day, with no loading dose, for 28 days
  • Minocycline Hydrochloride — DRUG
    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 — DRUG
    Capsule, 8 mg once on Day 1, then 16 mg daily for 27 days
  • Placebo — DRUG
    Capsule, 2x/day for 28 days

Study Details

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 Dates

Start date
Aug 1, 2024
Status verified
Dec 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
672 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention 1: Atorvastatin calcium (ATOR)
    By Mouth (PO) Twice a day (BID) 80 mg/day, with no loading dose, for 28 days
  • Active Comparator: 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
  • Active Comparator: 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
  • Placebo Comparator: Matching Placebo
    By Mouth (PO) Twice a day (BID) 2 capsules 2x/day

Primary Outcome Measure

Change in Glasgow Outcome Scale-Extended (GOSE 2-Way) [ Time Frame: 2 weeks to 3 months postinjury ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110-
Indiana University HealthIndianapolisIndiana46202-
University of KentuckyLexingtonKentucky40536-
Massachusetts General HospitalBostonMassachusetts02114-
Atrium Health Wake Forest BaptistCharlotteNorth Carolina28203-
Duke University Medical CenterDurhamNorth Carolina27710-
University of Cincinnati Medical CenterCincinnatiOhio45219-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of PittsburghPittsburghPennsylvania15213-
Vanderbilt University Medical CenterNashvilleTennessee37203-
The University of Texas at AustinAustinTexas78712-
Baylor College of MedicineHoustonTexas77030-
UTHealth HoustonHoustonTexas77030-
University of UtahSalt Lake CityUtah84132-
Virginia Commonwealth UniversityRichmondVirginia23298-
University of WashingtonSeattleWashington98104-
UW Health University HospitalMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CAIndiana University Health· Indianapolis, INUniversity of Kentucky· Lexington, KYMassachusetts General Hospital· Boston, MAAtrium Health Wake Forest Baptist· Charlotte, NCDuke University Medical Center· Durham, NC

Related Studies