Randomized Clinical Trial of Allopregnanolone for the Treatment of Severe Traumatic Brain Injury.

摘要

There is strong experimental support for the concept that allopregnanolone will be safe and have beneficial effects on disability when administered as a treatment following acute traumatic brain injury (TBI). This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe TBI. A Phase 2, adaptive, two-stage, placebo controlled, double blind, randomized clinical trial is being conducted at the UC Davis Medical Center, a Level 1 trauma center, and at additional medical centers with appropriate expertise. Allopregnanolone has been manufactured GMP for this trial. Intravenous product solutions have been developed. Subjects are being allocated to 3 dosing levels (1) placebo, (2) low (50 nM), and (3) high (150 nM). Key research accomplishments during the reporting period include: (1) actively recruiting subjects; (2) no adverse safety signals in subjects treated to date; (3) outcome data being collected as planned; (4) adequate steady state plasma levels achieved in the first cohort of patients receiving the low dose regimen; and (5) external sites have been enlisted to accelerate subject recruitment.