A Randomized Clinical Trial of Allopregnanolone for the Treatment of Severe Traumatic Brain Injury
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) by an innovative adaptive trial design consisting of two stages, in which safety and pharmacokinetics will be assessed in the first stage and adaptive allocation to the low and high doses will occur in the second stage. 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; (4) Finalizing contracts with external sites to accelerate recruitment.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2013
- Accession Number
- ADA596575
Entities
People
- Michael A. Rogawski
Organizations
- University of California