NCT06790095

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Cyclosporine (CsA)	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).
DRUG	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).

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2025-01-23
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study