Allopregnanolone in Chronic Complex Traumatic Brain Injury

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.

Timeline

Start

2026-09-01

Primary completion

2027-06-01

Completion

2027-06-01

Drugs

Indications