Accession Number:

ADA614116

Title:

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

Descriptive Note:

Annual rept. 30 Sep 2013-29 Sep 2014

Corporate Author:

CALIFORNIA UNIV DAVIS

Personal Author(s):

Report Date:

2014-10-01

Pagination or Media Count:

9.0

Abstract:

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.

Subject Categories:

  • Medicine and Medical Research
  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE