TRACK-TBI Precision Medicine Part 3 - Option II for Traumatic Brain Injury

This study is looking at whether Cyclosporine (CsA) can help people recover after a traumatic brain injury (TBI). Cyclosporine is a drug approved by the FDA for other uses, but it's not yet approved for TBI. Researchers want to see if it improves recovery compared to a placebo (a saline solution with no active drug). You might be able to join if you are 18-65 years old and have had a head injury that requires a CT scan, and can receive the study treatment within 24 hours of your injury. The study will measure changes in your recovery using a Disability Rating Score (DRS) from when you start the study until 4 weeks after your injury. This study plans to enroll 26 participants.

Study design: This is an interventional study comparing Cyclosporine to a placebo. It plans to enroll 26 participants.
What's involved: You would receive an intravenous (IV) injection of either Cyclosporine or placebo, starting with a loading dose over 2 hours, followed by a continuous IV infusion for 3 days (72 hours).
Compensation: Not stated in the trial record.
Follow-up: Your recovery will be measured from when you start the study until 4 weeks post-injury.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

TRACK-TBI Precision Medicine Part 3 - Option II

Enrolling by Invitation

PHASE2Ages 18–65InterventionalTreatment

University of California, San Francisco

~26 participants

Updated 2026-07-29 on ClinicalTrials.gov

What's tested:Cyclosporine (CsA)Placebo

At a glance

Recruiting sites

0 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Disability Rating Score (DRS)

Measured over Baseline to Week 4 post-injury

Conditions

Traumatic Brain Injury

Where it's being run

3 sites across 3 states

California1

Pennsylvania1

Utah1

Study leadership

Geoffrey Manley, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Evidence of contusion and/or

Evidence of traumatic axonal microvascular injury (TAMVI) 6. Initial Glial Fibrillary Acidic Protein (GFAP) blood level ≥ 1000 pg/mL ≤ 15000 pg/mL determined using a for Research Use Only (RUO) assay(s) or an Investigation Use Only (IUO) assay(s) 7. Participants able to undergo Magnetic Resonance Imaging (MRI) scans, no contraindications 8. Legally Authorized Representative (LAR) willing and able to provide informed consent 9. Participant/LAR able to read, speak, and understand English

Exclusion

Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (eGFR) (\<60 mL/minute/1.73 m2)

Major rhabdomyolysis with creatine kinase \> 5,000 IU/L 17. Current or medical history of hepatic disease (e.g., liver laceration at time of injury with Abbreviated Injury Scale for Liver Lacerations \> 1); cirrhosis), or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal lab value at the screening/baseline visit. 18. Current or medical history of serious chronic viral or fungal infection. 19. Current or medical history of active mycobacterial infection or anti-tuberculous treatment. 20. Medical history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody. 21. Any significant disease or disorder (including abnormal laboratory tests) which, in the opinion of the participating site investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study. 22. 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.

What this trial measures

Change in Disability Rating Score (DRS)Baseline to Week 4 post-injury
The primary outcome measure is to determine whether the intervention safely improves functional outcome in participants with TBI as compared to placebo, as measured by the change in the Disability Rating Score (DRS) score from Baseline to Week 4 post-injury.

Trialytics