Novel Regenerative Therapeutic in Chronic Complex TBI
VA Office of Research and Development
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.
Description
ALLO is a neurosteroid that exhibits multiple actions highly relevant to the treatment of chronic complex TBI. The investigators' recent human data suggest that ALLO is decreased in patients with TBI, suggesting that ameliorating deficits of this neurosteroid may be clinically therapeutic. In addition, multiple groups have reported ALLO reductions in patients with conditions that frequently co-occur with TBI, including depression and pain disorders. 132 Veterans with a history of mild TBI with co-occurring depression and pain symptoms (chronic complex TBI) will be randomized to either intraven…
Eligibility
- Age range
- 21–62 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 21-62 years of age, any ethnic group, either sex * History of mild TBI since 2001 and service in the U.S. Military since 9/11/01 (OEF/OIF/OND era) * The investigators will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force, with the exception of seizure and Glasgow Coma Scale score criteria (not available for these participants) with 1 or more of the following: * confusion or disorientation * loss of consciousness for 30 minutes or less * post-traumatic amnesia for less than 24 hours * and/or other transient ne…
Interventions
- DrugPlacebo
ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)
- DrugAllopregnanolone
ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)
- DrugAllopregnanolone
ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)
Location
- Durham VA Medical Center, Durham, NCDurham, North Carolina