Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans

PHASE2RecruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

September 6, 2024

Primary Completion Date

August 30, 2026

Study Completion Date

August 30, 2026

Conditions
Traumatic Brain InjuryTBI
Interventions
DRUG

Pregnenolone

Pregnenolone 250 mg BID x 14 DAYS, followed by Pregnenolone 500 mg BID x 14 DAYS, followed by Pregnenolone 1000 mg BID x thereafter for the remainder of the 8-week trial

DRUG

Placebo

Same as active comparator, except placebo dispensed.

Trial Locations (2)

27705

NOT_YET_RECRUITING

Duke University School of Medicine, Durham

RECRUITING

Durham VA Health Care System, Durham

All Listed Sponsors
lead

Christine Marx, MD

OTHER