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NOT YET RECRUITING
NCT04003285
PHASE2

Allopregnanolone in Chronic Complex Traumatic Brain Injury

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Novel Regenerative Therapeutic in Chronic Complex TBI

Key Details

Gender

All

Age Range

21 Years - 62 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2026-06-01

Completion Date

2027-06-01

Last Updated

2026-03-16

Healthy Volunteers

No

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)

Locations (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States