Multi-Drug Therapy for Traumatic Brain Injury

(APT-TBI-01 Trial)

Recruiting at1 trial location

Overseen by Geoffrey Manley, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Geoffrey Manley, MD PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults aged 18-65 with a recent non-penetrating head injury and specific CT scan findings. Participants must have certain protein levels in their blood, be able to undergo MRI scans without sedation, use birth control if applicable, and not have severe allergies or organ dysfunction. They should also not be on the study drugs already or enrolled in another interventional study.

Inclusion Criteria

My GFAP blood level is between 100 and 15,000 pg/ml.

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

Participants able to undergo magnetic resonance imaging (MRI) scans, no contraindications or need for sedation

Exclusion Criteria

Hypersensitivity or intolerance to investigational products or the investigational products respective classes

Currently pregnant or currently breastfeeding or planning on becoming pregnant in the next 6 months

I am currently taking or cannot take the trial drug due to health reasons.

Treatment Details

Interventions

• Atorvastatin Calcium (Statins)
• Candesartan Cilexetil (Angiotensin II Receptor Blocker)
• Minocycline Hydrochloride (Antibiotic)
• Placebo (Drug)

Trial Overview The trial tests Atorvastatin Calcium, Minocycline Hydrochloride, Candesartan Cilexetil against a placebo to see if they improve recovery from traumatic brain injury (TBI). These FDA-approved drugs are used 'off-label' here since they're not specifically approved for TBI treatment.

Participant Groups

Group I: Intervention 1: Atorvastatin calcium (ATOR) Active Control 1 Intervention

By Mouth (PO) Twice a day (BID) 80 mg/day, with no loading dose, for 28 days

Group II: Intervention 2: Minocycline hydrochloride (MINO) Active Control 1 Intervention

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

Group III: Intervention 3: Candesartan cilexetil (CAND) Active Control 1 Intervention

By Mouth (PO) Twice a day (BID) 8 mg once on Day 1, then 16 mg daily for 27 days

Group IV: Matching Placebo Placebo Group 1 Intervention

By Mouth (PO) Twice a day (BID) 2 capsules 2x/day

Atorvastatin Calcium is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular disease

Approved in Japan as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular disease

Approved in China as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular disease

Approved in Switzerland as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular disease

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences