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Allopregnanolone in Chronic Complex Traumatic Brain Injury

NCT04003285 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-03-16

No results posted yet for this study

Summary

This study will determine if allopregnanolone (ALLO) improves depression and pain symptoms in patients who have a history of mild traumatic brain injury (TBI) \[primary endpoints\]. The investigators will also determine if ALLO improves functional outcome \[secondary endpoint\]. Participants in this study will receive an intravenous infusion of either ALLO or placebo. Behavioral assessments will be conducted during the infusion and at several time points post-infusion.

Conditions

  • Traumatic Brain Injury (TBI)

Interventions

DRUG

Placebo

ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)

DRUG

Allopregnanolone

ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)

DRUG

Allopregnanolone

ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Christine E. Marx, MD MA · Durham VA Medical Center, Durham, NC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04003285 on ClinicalTrials.gov