A Randomized Clinical Trial of Allopregnanolone for the Treatment of Severe Traumatic Brain Injury
Annual rept. 30 Sep 2009-29 Sep 2010
CALIFORNIA UNIV DAVIS
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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 severe TBI. A phase II, fixed dose, placebo controlled, double blind, randomized clinical trial will be undertaken at the UC Davis Medical Center, a Level 1 trauma center. A subawardee Medkura Pharmaceuticals assisted by SAFC has been engaged to provide pyrogen-free allopregnanolone manufactured according to Current Good Manufacturing Practices cGMP. Intravenous solutions of active drug and placebo will be formulated within the GMP Facility at the UC Davis School of Medicine. A subawardee, PRA International a contract research organization, will be responsible for study management so that the trial will be compliant with FDA Good Clinical Practice requirements. Key research accomplishments during the reporting period include the development of a synthetic route for large scale manufacturing of pharmaceutical grade allopregnanolone of high purity. In addition, an HPLC assay method for allopregnanolone was developed.
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