NCT04003285View on ClinicalTrials.gov

Allopregnanolone in Chronic Complex Traumatic Brain Injury

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

February 1, 2026

Primary Completion Date

February 1, 2027

Study Completion Date

February 1, 2027

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)

Trial Locations (1)

27705-3875

Durham VA Medical Center, Durham, NC, Durham

All Listed Sponsors
lead

VA Office of Research and Development

FED