“Despite extensive preclinical data and two promising single-center trials, progesterone was not associated with any benefit over placebo, as measured by the GOS-E score at 6 months, in this large, multicenter clinical trial,” wrote lead author Dr. David W. Wright of Emory University, Atlanta, and his associates.
“The PROTECT III trial joins a growing list of negative or inconclusive trials in the arduous search for a treatment for TBI. To date, no treatment has succeeded at the confirmatory trial stage,” the researchers noted.
The SYNAPSE trial was funded by BHR Pharma, a division of Besins Healthcare. PROTECT III was funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences; the Emory Emergency Neurosciences Laboratory at Emory University, Atlanta; and Grady Memorial Hospital, Atlanta. Several coauthors for each study had their own disclosures, as well.