Traumatic Brain InjuryPhase 2PM-003NCT06790095
TRACK-TBI Precision Medicine Part 3 - Option II
A Phase 2 study testing Cyclosporine (CsA) in people with Traumatic Brain Injury, run by University of California, San Francisco at 4 sites in United States.
Trial 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 drug listed below is approved by the U.S. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Cyclosporine (CsA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Jul 2026to Mar 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-65 years of age, inclusive)
- Head injury warranting clinical evaluation with a non-contrast cranial CT based on American College of Emergency Physicians (ACEP) Centers for Disease Control and Prevention (CDC) clinical policy for TBI imaging.
- Able to receive investigational product within 24 hours of head injury.
- Closest, prior to randomization GCS score of 3 to 12 (motor score < 6)
- Evidence of TBI on imaging, confirmed by:
- Evidence of contusion and/or
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- Evidence of traumatic axonal microvascular injury (TAMVI)
- 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)
- Participants able to undergo Magnetic Resonance Imaging (MRI) scans, no contraindications
- Legally Authorized Representative (LAR) willing and able to provide informed consent
- Participant/LAR able to read, speak, and understand English
Who cannot join
- Isolated epidural hematoma
- Bilaterally fixed dilated pupils in the absence of paralytic medications, or evidence of herniation on cranial CT
- 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
- Order for comfort care placed prior to enrollment
- Current enrollment in another interventional study
- Currently pregnant or currently breastfeeding or planning on becoming pregnant in the next 6M
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- Current incarceration or in custody
- On psychiatric hold (e.g. codes 5150, 5250)
- Ongoing pre-injury therapy with the Investigational Product (IP), currently receiving immunosuppressive therapy, chemotherapy, or any contraindicated medications (see CsA Drug contraindications/caution table in the Pharmacy Manual)
- Current or medical history of any allergic reactions and/or anaphylactic reactions towards cyclosporine (CsA) and cremophor (also known as kolliphor®)
- Severe polytrauma or previous conditions that would preclude conducting any study activities
- Any spinal cord injury of grade A to D on the American Spinal Injury Association (ASIA) Impairment Scale
- Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
- Body Mass Index (BMI) >35
- Hemodynamic instability, per participating site physician investigator clinical judgement
- Current or medical history of nephrectomy, renal dysfunction, significant renal failure, or high-risk for renal failure, defined as:
- Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (eGFR) (<60 mL/minute/1.73 m2)
- Major rhabdomyolysis with creatine kinase > 5,000 IU/L
- 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.
- Current or medical history of serious chronic viral or fungal infection.
- Current or medical history of active mycobacterial infection or anti-tuberculous treatment.
- Medical history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody.
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Utah
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Part 3 - Option II
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 drug listed below is approved by the U.S. Food and Drug Administration (FDA) but is being used "off-label" in this study. This means that the drug is not currently approved to treat TBI.
- Conditions
- Traumatic Brain Injury
- Being tested
- Cyclosporine (CsA), Placebo
- Keywords
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine (CsA)Drug
Also called Sandimmune®
Intravenous (IV) injection, loading dose of 2.5 mg/kg (diluted in 0.9% NaCl to a final volume of 50 ml) given over 2 hours, immediately followed by a continuous IV infusion of of 5 mg/kg/day (diluted in 0.9% NaCl to a final volume of 250 ml) for 3 days (72-hour).
PlaceboDrug
Intravenous (IV) injection of 0.9% NaCl with the same dosing strategy as CsA: "loading dose" given over 2 hours, immediately followed by a continuous IV infusion for 3 days (72-hour).
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine (CsA) | Active comparator | Intravenous (IV) injection, 2.5 mg/kg loading dose given over 2 hours, followed by a 3-day (72-hour) constant IV infusion of 5 mg/kg/day. Receives: Drug: Cyclosporine (CsA) |
| Matching Placebo | Placebo comparator | Intravenous (IV) injection of 0.9% NaCl over 74 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability Rating Score (DRS)
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.
Measured: Baseline to Week 4 post-injury
Secondary outcomes (12)
Change in Blood-based biomarker (Neurofilament light chain)
To determine whether the intervention lowers the rising plasma Neurofilament light chain (NfL) levels up to W2 post-injury in participants with TBI as compared to placebo.
Measured: Baseline to Week 2 post-injury
Change in Blood-based biomarker (GFAP)
To determine whether the intervention lowers the plasma GFAP levels up to W2 post-injury as compared to placebo.
Measured: Baseline to Week 2 post-injury
Change in Blood-based biomarker (UCH-L1)
To determine whether the intervention lowers the plasma UCH-L1 levels up to Week 2 post-injury in participants with TBI as completed to placebo.
Measured: Baseline to Week 2 post-injury
Post-TBI symptom outcome (CRSR-FAST)
To determine the effect of intervention on the change in the number of behavioral signs of consciousness present on the Coma Recovery Scale- Revised For Accelerated Standardized Testing (CRSR-FAST) from Baseline to W4 post-injury as compared to placebo.
Measured: Baseline to Week 4 post-injury
Imaging biomarkers
To determine whether the intervention results in improved imaging biomarkers compared to placebo measured by: 1) the change in white matter tract using MRI diffusion tensor imaging (DTI), and 2) change in total brain volumetrics using MRI T1 MPRAGE, from Week 2 to Month 6.
Measured: Week 2 to Month 6
Post-TBI functional outcomes (DRS)
To determine the effect of intervention on functional outcomes, as measured by:
- Change in the Disability Rating Scale (DRS) from Baseline to Month 3 and Baseline to Month 6
Measured: Baseline to Month 3 and Baseline to Month 6
Post-TBI functional outcomes (FSE)
To determine the effect of intervention on functional outcomes, as measured by:
II. Functional Status Examination (FSE) score at Week 2, Week 4, Month 3 and Month 6
Measured: Week 2, Week 4, Month 3 and Month 6
Post-TBI functional outcomes (GOSE-TBI)
To determine the effect of intervention on functional outcomes, as measured by:
III. Glasgow Outcome Scale Extended (TBI Version) (GOSE-TBI) score at Week 2, Week 4, Month 3 and Month 6.
Measured: Week 2, Week 4, Month 3 and Month 6
Post-TBI cognitive outcome (BTACT)
To determine the effect of the intervention on cognitive outcome, as measured by the Brief Test of Adult Cognition by Telephone (BTACT) Composite z-score at Week 4, Month 3 and Month 6.
Measured: Week 4, Month 3, and Month 6
Post-TBI quality of life and patient-reported outcomes (QOLIBRI)
To determine the effect of intervention on quality of life and other patient-reported outcomes (PRO), as measured by the Quality of Life Brain Injury (QOLIBRI) at Month 3 and Month 6.
Measured: Month 3 and Month 6
Post-TBI quality of life and patient-reported outcomes (RPQ)
To determine the effect of intervention on quality of life and other patient-reported outcomes (PRO), as measured by the Rivermead Post Concussion Symptoms Questionnaire (RPQ) at Month 3 and Month 6.
Measured: Month 3 and Month 6
Post-TBI quality of life and patient-reported outcomes (Caregiver Burden)
To determine the effect of intervention on quality of life and other patient-reported outcomes (PRO), as measured by the Caregiver Burden at Week 2, Month 3, and Month 6.
Measured: Week 2, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start2 Jul 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Geoffrey Manley, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790095
- Sponsor's protocol ID
- PM-003
- Acronym
- PM-003
- Status last verified
- Oct 2026
- First submitted
- 17 Jan 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through the Federal Interagency TBI Research (FITBIR) Database.