Cyclosporine for Traumatic Brain Injury
(PM-003 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGeoffrey Manley, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals who have suffered from subcortical brain damage or traumatic brain injury. Participants must meet certain health criteria to be included, but specific inclusion details are not provided here.

Inclusion Criteria

I am between 18 and 65 years old.

Initial GFAP blood level >1000 pg/mL ≤ 15000 pg/mL determined using a RUO or IUO assay

My recent GCS score was between 3 and 8.

+5 more

Exclusion Criteria

I have a blood clot between my skull and brain.

My pupils are dilated and do not respond to light, not due to medications or brain herniation.

On psychiatric hold (e.g. Codes 5150, 5250)

+19 more

Participant Groups

The study is testing the effectiveness of Cyclosporine (CsA), an FDA-approved drug used off-label, against a placebo in improving recovery after traumatic brain injury. Recovery progress will be monitored throughout the study.

2Treatment groups

Active Control

Placebo Group

Group I: Cyclosporine (CsA)Active Control1 Intervention

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.

Group II: Matching PlaceboPlacebo Group1 Intervention

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