NCT05826912

Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 672 (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 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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Atorvastatin Calcium	Capsule, 80 mg/day, with no loading dose, for 28 days
DRUG	Minocycline Hydrochloride	Capsule, 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
DRUG	Candesartan Cilexetil	Capsule, 8 mg once on Day 1, then 16 mg daily for 27 days
DRUG	Placebo	Capsule, 2x/day for 28 days

Timeline

• Start date: 2024-08-01
• Primary completion: 2028-08-31
• Completion: 2029-08-31
• First posted: 2023-04-24
• Last updated: 2025-12-22

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study