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NCT04003285 · ClinicalTrials.gov registry record · Phase 2
Allopregnanolone in Chronic Complex Traumatic Brain Injury
A Phase 2 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
NCT04003285: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT04003285 is a Phase 2 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003285, a Phase 2 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
Study 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.
Primary Outcome
The Brief Pain Inventory, Short Form (BPI-SF) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hou
Interventions
- DRUG Placebo
- DRUG Allopregnanolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
What is known before NCT04003285 opens enrollment
NCT04003285 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04003285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04003285 about?
NCT04003285 is a clinical study titled "Allopregnanolone in Chronic Complex Traumatic Brain Injury". 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...
What is the current status of trial NCT04003285?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2026-09-01. Estimated completion is 2027-06-01.
What interventions are being tested in trial NCT04003285?
The interventions under investigation include: Placebo (DRUG), Allopregnanolone (DRUG).
Who is sponsoring clinical trial NCT04003285?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04003285's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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