[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06790095":3,"trial-entities:NCT06790095":144,"trial-summary:NCT06790095":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":46,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":93,"eligibility_criteria":94,"std_ages":102,"locations":105,"central_contacts":130,"overall_officials":131,"references":135,"see_also_links":136},"NCT06790095","PM-003","TRACK-TBI Precision Medicine Part 3 - Option II","Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Part 3 - Option II","ENROLLING_BY_INVITATION","2027-03","2026-07","2026-07-29","2026-07-02","University of California, San Francisco","OTHER",true,"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.",null,[19],"Traumatic Brain Injury",[19],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},26,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Cyclosporine (CsA)","Intravenous (IV) injection, loading dose of 2.5 mg\u002Fkg (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\u002Fkg\u002Fday (diluted in 0.9% NaCl to a final volume of 250 ml) for 3 days (72-hour).",[31],[35],"Sandimmune®",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Placebo","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).",[40],"Matching Placebo",[42],{"measure":43,"description":44,"timeFrame":45},"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",[47,51,54,57,60,64,68,72,75,79,83,86],{"measure":48,"description":49,"timeFrame":50},"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.","Baseline to Week 2 post-injury",{"measure":52,"description":53,"timeFrame":50},"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.",{"measure":55,"description":56,"timeFrame":50},"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.",{"measure":58,"description":59,"timeFrame":45},"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.",{"measure":61,"description":62,"timeFrame":63},"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.","Week 2 to Month 6",{"measure":65,"description":66,"timeFrame":67},"Post-TBI functional outcomes (DRS)","To determine the effect of intervention on functional outcomes, as measured by:\n\nI. Change in the Disability Rating Scale (DRS) from Baseline to Month 3 and Baseline to Month 6","Baseline to Month 3 and Baseline to Month 6",{"measure":69,"description":70,"timeFrame":71},"Post-TBI functional outcomes (FSE)","To determine the effect of intervention on functional outcomes, as measured by:\n\nII. Functional Status Examination (FSE) score at Week 2, Week 4, Month 3 and Month 6","Week 2, Week 4, Month 3 and Month 6",{"measure":73,"description":74,"timeFrame":71},"Post-TBI functional outcomes (GOSE-TBI)","To determine the effect of intervention on functional outcomes, as measured by:\n\nIII. Glasgow Outcome Scale Extended (TBI Version) (GOSE-TBI) score at Week 2, Week 4, Month 3 and Month 6.",{"measure":76,"description":77,"timeFrame":78},"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.","Week 4, Month 3, and Month 6",{"measure":80,"description":81,"timeFrame":82},"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.","Month 3 and Month 6",{"measure":84,"description":85,"timeFrame":82},"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.",{"measure":87,"description":88,"timeFrame":89},"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.","Week 2, Month 3, and Month 6","ALL","18 Years","65 Years",false,{"inclusion":95,"exclusion":98,"raw_text":101},[96,97],"Evidence of contusion and\u002For","Evidence of traumatic axonal microvascular injury (TAMVI) 6. Initial Glial Fibrillary Acidic Protein (GFAP) blood level ≥ 1000 pg\u002FmL ≤ 15000 pg\u002FmL 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\u002FLAR able to read, speak, and understand English",[99,100],"Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (eGFR) (\\\u003C60 mL\u002Fminute\u002F1.73 m2)","Major rhabdomyolysis with creatine kinase \\> 5,000 IU\u002FL 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\u002Fbaseline 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.","Inclusion Criteria:\n\n1. Adults (18-65 years of age, inclusive)\n2. 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.\n3. Able to receive investigational product within 24 hours of head injury.\n4. Closest, prior to randomization GCS score of 3 to 12 (motor score \\\u003C 6)\n5. Evidence of TBI on imaging, confirmed by:\n\n   * Evidence of contusion and\u002For\n   * Evidence of traumatic axonal microvascular injury (TAMVI)\n6. Initial Glial Fibrillary Acidic Protein (GFAP) blood level ≥ 1000 pg\u002FmL ≤ 15000 pg\u002FmL determined using a for Research Use Only (RUO) assay(s) or an Investigation Use Only (IUO) assay(s)\n7. Participants able to undergo Magnetic Resonance Imaging (MRI) scans, no contraindications\n8. Legally Authorized Representative (LAR) willing and able to provide informed consent\n9. Participant\u002FLAR able to read, speak, and understand English\n\nExclusion Criteria:\n\n1. Isolated epidural hematoma\n2. Bilaterally fixed dilated pupils in the absence of paralytic medications, or evidence of herniation on cranial CT\n3. 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\n4. Order for comfort care placed prior to enrollment\n5. Current enrollment in another interventional study\n6. Currently pregnant or currently breastfeeding or planning on becoming pregnant in the next 6M\n7. Current incarceration or in custody\n8. On psychiatric hold (e.g. codes 5150, 5250)\n9. Ongoing pre-injury therapy with the Investigational Product (IP), currently receiving immunosuppressive therapy, chemotherapy, or any contraindicated medications (see CsA Drug contraindications\u002Fcaution table in the Pharmacy Manual)\n10. Current or medical history of any allergic reactions and\u002For anaphylactic reactions towards cyclosporine (CsA) and cremophor (also known as kolliphor®)\n11. Severe polytrauma or previous conditions that would preclude conducting any study activities\n12. Any spinal cord injury of grade A to D on the American Spinal Injury Association (ASIA) Impairment Scale\n13. Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke\n14. Body Mass Index (BMI) \\>35\n15. Hemodynamic instability, per participating site physician investigator clinical judgement\n16. Current or medical history of nephrectomy, renal dysfunction, significant renal failure, or high-risk for renal failure, defined as:\n\n    * Creatinine Clearance (CrCl) or estimated Glomerular Filtration Rate (eGFR) (\\\u003C60 mL\u002Fminute\u002F1.73 m2)\n    * Major rhabdomyolysis with creatine kinase \\> 5,000 IU\u002FL\n17. 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\u002Fbaseline visit.\n18. Current or medical history of serious chronic viral or fungal infection.\n19. Current or medical history of active mycobacterial infection or anti-tuberculous treatment.\n20. Medical history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody.\n21. 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.\n22. 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.",[103,104],"ADULT","OLDER_ADULT",[106,114,122],{"facility":13,"city":107,"state":108,"zip":109,"country":110,"geoPoint":111},"San Francisco","California","94110","United States",{"lat":112,"lon":113},37.77493,-122.41942,{"facility":115,"city":116,"state":117,"zip":118,"country":110,"geoPoint":119},"University of Pittsburgh","Pittsburgh","Pennsylvania","15213",{"lat":120,"lon":121},40.44062,-79.99589,{"facility":123,"city":124,"state":125,"zip":126,"country":110,"geoPoint":127},"University of Utah","Salt Lake City","Utah","84132",{"lat":128,"lon":129},40.76078,-111.89105,[],[132],{"name":133,"affiliation":13,"role":134},"Geoffrey Manley, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[137,140,142],{"label":138,"url":139},"Related Info","https:\u002F\u002Ftracktbi.ucsf.edu\u002F",{"label":138,"url":141},"https:\u002F\u002Ftracktbi.ucsf.edu\u002Fpublications",{"label":138,"url":143},"https:\u002F\u002Ftracktbinet.ucsf.edu\u002F",{"nct_id":4,"conditions":145,"biomarkers":147},[146],"Traumatic Encephalopathy",[148],"GFAP Gene",{"nct_id":4,"found":15,"summary":150,"prompt_version":160},{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This is an interventional study comparing Cyclosporine to a placebo. It plans to enroll 26 participants.","completed","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.","Your recovery will be measured from when you start the study until 4 weeks post-injury.",123,"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).","Not stated in the trial record.",[31,37],"v2"]