Allopregnanolone in Chronic Complex Traumatic Brain Injury (NCT04003285)
Novel Regenerative Therapeutic in Chronic Complex TBI
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Durham VA Medical Center, Durham, NC — Durham, North Carolina
Age range: 21 Years to 62 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Durham VA Medical Center, Durham, NC — Durham, North Carolina
📞 Contact the Study Coordinator
Phone: (919) 286-0411
Email: christine.marx@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Traumatic Brain Injury (TBI)
- LearningRx Cognitive Training for Brain Injury — Colorado Springs, Colorado
- Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD — Durham, North Carolina
- Hemodynamic ABI Monitor — Chicago, Illinois
Explore by condition: All Traumatic Brain Injury (TBI) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.