Allopregnanolone in Chronic Complex Traumatic Brain Injury

ClinicalTrials.gov ID: NCT04003285

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Official title

Novel Regenerative Therapeutic in Chronic Complex TBI

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04003285
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: VA Office of Research and Development; Federal
Enrollment: 132 participants

Conditions and interventions

Conditions

Traumatic Brain Injury (TBI)

Interventions

Placebo Drug
Allopregnanolone Drug

Drug

Eligibility (public fields only)

Age range: 21 Years to 62 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 1, 2026 (Estimated)
Primary completion: Jun 1, 2027 (Estimated)
Completion: Jun 1, 2027 (Estimated)
Last update posted: Oct 19, 2026

2026 – 2027

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Durham VA Medical Center, Durham, NC	Durham	North Carolina	27705-3875	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04003285, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 19, 2026 · Synced Nov 11, 2026