A Phase 2 interventional study of Atorvastatin Calcium and Minocycline Hydrochloride in Traumatic Brain Injury, sponsored by University of California, San Francisco. Enrolling by invitation at 18 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
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 drugs listed below are approved by the U.S. Food and Drug Administration (FDA) but are being used "off-label" in this study. This means that the drugs are 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 672 is above 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.
Exclusion Criteria:
By Mouth (PO) Twice a day (BID) 80 mg/day, with no loading dose, for 28 days
Drug: Atorvastatin Calcium
By Mouth (PO) Twice a day (BID) 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
Drug: Minocycline Hydrochloride
By Mouth (PO) Twice a day (BID) 8 mg once on Day 1, then 16 mg daily for 27 days
Drug: Candesartan Cilexetil
By Mouth (PO) Twice a day (BID) 2 capsules 2x/day
Drug: Placebo
Capsule, 80 mg/day, with no loading dose, for 28 days
Also known as: ATOR
Capsule, 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
Also known as: MINO
Capsule, 8 mg once on Day 1, then 16 mg daily for 27 days
Also known as: CAND
Capsule, 2x/day for 28 days
Change in Glasgow Outcome Scale-Extended (GOSE 2-Way)
Functional impairment due only to the TBI will be measured using the GOSE Scale-Extended (GOSE 2-Ways). The score ranges from 1-8, with higher scores indicating better recovery. Change will be measured from Week 2 to Month 3 postinjury and compared to placebo.
Time frame: 2 weeks to 3 months postinjury
Change in Blood-based biomarkers (Neurofilament light chain)
Neurofilament light chain (NfL) levels postinjury in participants with TBI will be measured and compared to placebo
Time frame: Week 2
Blood-based biomarker (GFAP)
GFAP levels postinjury in participants with TBI as compared to placebo
Time frame: Week 2
Imaging biomarkers
Comparison of MRI diffusion tensor imaging (DTI) Axial Diffusivity (AD) measure using the average of 4 long association/projections tracts: (i) Anterior Limb of Internal Capsule (ALIC); (ii) External Capsule (EC); (iii) Superior Corona Radiata (SCR); and (iv) Superior Longitudinal Fasciculus (SLF). Change will be measured from 2 Weeks to 3 Months postinjury.
Time frame: 2 weeks to 3 months postinjury
Post-TBI cognitive outcome (BTACT)
Neurocognitive impairment due to TBI will be measured using the Brief Test of Adult Cognition by Telephone (BTACT). Change will be measured by composite z-score from Day 3 to Week 4 postinjury
Time frame: Day 3 to Week 4 postinjury
Post-TBI symptom outcome (Rivermead)
Post-concussive symptoms due to TBI as measured by the change in Rivermead Post Concussion Symptoms Questionnaire (RPQ) Total score (0-64) from Day 3 to Week 4. Higher scores indicate more severe symptoms
Time frame: Day 3 to Week 4
Plan to share: Yes — Data will be made available through the Federal Interagency TBI Research (FITBIR) Database.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of California, San Francisco