Clinical Trials Logo
  1. Home
  2. Traumatic Brain Injury (TBI)
  3. NCT04003285

Allopregnanolone in Chronic Complex Traumatic Brain Injury — ALLO  

Traumatic Brain Injury (TBI) Clinical Trial

Official title:
Novel Regenerative Therapeutic in Chronic Complex TBI

Clinical Trial 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.

Clinical Trial 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 intravenous placebo or ALLO (3 groups/44 participants per group: placebo, lower dose ALLO, higher dose ALLO). Following a loading dose, Veterans will receive placebo or ALLO infusion targeted to achieve serum ALLO levels of 0 nM (placebo), 50 nM (ALLO lower dose), or 150nM (ALLO higher dose). Behavioral assessments will be conducted during the infusion, post-taper, and 24 hours post-infusion. In addition, the investigators will conduct behavioral assessments 7 days and 14 days post-infusion. The investigators hypothesize that ALLO will be well-tolerated in patients with complex TBI, and that this intervention may reduce depression and pain symptoms (in addition to potentially improving function). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04003285
Study type Interventional
Source VA Office of Research and Development
Contact Christine E Marx, MD MA
Phone (919) 286-0411
Email christine.marx@va.gov
Status Not yet recruiting
Phase Phase 2
Start date March 1, 2024
Completion date September 30, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT02878577 - Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury
Active, not recruiting NCT02918994 - LearningRx Cognitive Training for TBI N/A
Completed NCT02524067 - Modified Environment for Agitation in Patients With TBI N/A
Completed NCT01760785 - Valproate for Mood Swings and Alcohol Use Following Head Injury N/A
Recruiting NCT05033444 - A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers Phase 1
Completed NCT01750268 - Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI Phase 4
Recruiting NCT01512524 - Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury N/A
Completed NCT04796207 - The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes N/A
Completed NCT02657135 - Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury N/A
Completed NCT01956136 - Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury N/A
Withdrawn NCT02356861 - LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans N/A
Recruiting NCT04930146 - Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients N/A
Withdrawn NCT01891383 - Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
Completed NCT02764983 - Occupational Therapy Driving Intervention for Returning Combat Veterans. N/A
Withdrawn NCT01779427 - Attention Intervention Management N/A
Completed NCT01118195 - Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans N/A
Completed NCT01547780 - Translocator Protein and Inflammation After Traumatic Brain Injury Phase 1/Phase 2
Recruiting NCT03874208 - Prediction for Coma Recovery With Comaweb N/A
Completed NCT03314584 - Managing MTBI-related Headaches With rTMS N/A
Completed NCT02172703 - Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage N/A