drugset / Trial / NCT05826912
Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury
Phase 2
Enrolling by invitation
672 enrolled
University of California, San Francisco
United States Department of Defense · collab
RandomizedParallel-groupQuadruple-blindTreatment
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 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.
Timeline
- Start
- 2024-08-01
- Primary completion
- 2028-08-31
- Completion
- 2029-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atorvastatin | Small molecule | 80 mg | Oral |
| Comparator | Candesartan cilexetil | Unknown | 16 mg | Oral |
| Comparator | Minocycline | Small molecule | 100 mg | Oral |