A Phase 2 interventional study of Cyclosporine (CsA) and Placebo in Traumatic Brain Injury, sponsored by University of California, San Francisco. Enrolling by invitation at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's planned enrollment of 26 is below the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Evidence of TBI on imaging, confirmed by:
Exclusion Criteria:
Current or medical history of nephrectomy, renal dysfunction, significant renal failure, or high-risk for renal failure, defined as:
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)
Intravenous (IV) injection of 0.9% NaCl over 74 hours.
Drug: Placebo
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®
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).
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.
Time frame: Baseline to Week 4 post-injury
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 2 to Month 6
Post-TBI functional outcomes (DRS)
To determine the effect of intervention on functional outcomes, as measured by: I. Change in the Disability Rating Scale (DRS) from Baseline to Month 3 and Baseline to Month 6
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 2, Month 3, and Month 6
Plan to share: Yes — Data will be made available through the Federal Interagency TBI Research (FITBIR) Database.
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University of California, San Francisco