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

NCT05826912 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 672

Last updated 2025-12-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Geoffrey Manley, MD PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2028-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826912 on ClinicalTrials.gov