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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04003285
The ClinicalTrials.gov registry entry for NCT04003285 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04003285 reports 0 study locations.
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.
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