A Randomized Clinical Trial of Allopregnanolone for the Treatment of Severe Traumatic Brain Injury
Technical Report,30 Sep 2009,29 Sep 2015
University of California, Davis Davis United States
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A variety of lines of evidence support the possibility that allopregnanolone will be safe and have beneficial effects on disability when administered as a treatment following acute traumatic brain injury TBI. In this project, a method was developed to manufacture pharmaceutical grade allopregnanolone, which was formulated in intravenous solutions. Regulatory approval was obtained to administer the formulations in the context of a clinical trial in moderate to severe TBI. A placebo controlled, double blind, randomized clinical trial was conducted at the UC Davis Medical Center, a Level1 trauma center. A dosing regimen based on pharmacokinetic modeling was developed to obtain steady state plasma levels of 50 nM and 150 nM. A total of 13 subjects were enrolled. No treatment related adverse effects were noted. Pharmacokinetic studies conducted in the context of the trial provide a basis for dosing of allopregnanolone in future studies. No safety concerns were raised by the clinical trial. Further research is required to determine if all opregnanolone is efficacious as a treatment for TBI.