TRACK-TBI Precision Medicine Part 3 - Option II

NCT06790095 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: PM-003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 4 post-injury

Secondary Outcomes (12)

• Change in Blood-based biomarker (Neurofilament light chain)

  Baseline to Week 2 post-injury

• Change in Blood-based biomarker (GFAP)

  Baseline to Week 2 post-injury

• Change in Blood-based biomarker (UCH-L1)

  Baseline to Week 2 post-injury

• Post-TBI symptom outcome (CRSR-FAST)

  Baseline to Week 4 post-injury

• Imaging biomarkers

  Week 2 to Month 6

Study Arms (2)

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.

Drug: Cyclosporine (CsA)

Matching Placebo

PLACEBO COMPARATOR

Intravenous (IV) injection of 0.9% NaCl over 74 hours.

Drug: Placebo

Interventions

Cyclosporine (CsA) DRUG

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).

Also known as: Sandimmune®

Cyclosporine (CsA)

Placebo DRUG

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).

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-65 years of age, inclusive)
• Presents to a participating enrollment site and is able to receive treatment within 24 hours of 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.
• Closest, prior to randomization GCS score of 3 to 8
• Evidence of TBI on cranial CT, confirmed by:
• Evidence of contusion and/or
• Evidence of traumatic axonal microvascular injury (TAMVI)
• Initial 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 or Spanish (participating site dependent, where available), including the Informed Consent Form (ICF)

You may not qualify if:

• 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
• 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 or any contraindicated medications (see CsA Drug contraindications/caution table in Manual of Procedures)
• Current or medical history of any allergic reactions and/or anaphylactic reactions towards 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Geoffrey Manley, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Shared scientific data will be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first.
• Access Criteria: FITBIR qualified investigators will be provided access

Locations

US (1)