Allopregnanolone in Chronic Complex Traumatic Brain Injury

Part of paid clinical trials in Durham, North Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT04003285
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury (TBI)

Eligibility Criteria

Sex
ALL
Age
21 Years - 62 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)
  • Allopregnanolone — DRUG
    ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)
  • Allopregnanolone — DRUG
    ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo
    ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)
  • Experimental: ALLO 50 nM
    ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)
  • Experimental: ALLO 150 nM
    ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)

Primary Outcome Measure

Brief Pain Inventory, Short Form (BPI-SF) Change [ Time Frame: 6 hours, 24 hours, 7 days, and 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Christine E Marx, MD MA
[email protected]
(919) 286-0411
Christine E. Marx, MD MA (PRINCIPAL_INVESTIGATOR)

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By research site
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