Progesterone offers no significant benefit in traumatic brain injury clinical trial

PUBLIC RELEASE DATE:

10-Dec-2014

Contact: Holly Korschun hkorsch@emory.edu 404-727-3990 Emory Health Sciences @emoryhealthsci

Treatment of acute traumatic brain injury with the hormone progesterone provides no significant benefit to patients when compared with placebo, a NIH-funded phase III clinical trial has concluded.

The results are scheduled for publication Dec. 10 in the New England Journal of Medicine.

The study, named ProTECT III, involved 49 trauma centers across the United States between July 2009 and November 2013. The study was originally planned to include 1,140 patients, but was stopped after 882 patients because safety monitors determined that additional enrollment would be futile.

Survival and favorable outcomes, measured by improvements in patients' Glasgow Coma Scores, were not significantly different in the progesterone-treated group than in the placebo-treated group. Favorable outcomes occurred in 51 percent of those who received progesterone and 56 percent of those who received placebo. Mortality after six months was 18.8 percent for progesterone and 15.7 percent for placebo.

"These results are plainly disappointing," says David Wright, MD, associate professor and vice chair for research in emergency medicine at Emory University School of Medicine, who served as lead investigator for the national study. "The preclinical data on progesterone's neuroprotective effects are compelling, but we were not able to translate them to a multi-center clinical trial with human traumatic brain injury."

The study was funded by the National Institute of Neurological Disorders and Stroke and organized as part of the NETT (Neurological Emergencies Treatment Trials) network, with the University of Michigan providing oversight and coordination and the Medical University of South Carolina providing data analysis. Michael Frankel, MD, professor of neurology at Emory, was site principal investigator at Grady Memorial Hospital.

Similar results from a separate industry-funded clinical trial of progesterone in traumatic brain injury are scheduled for publication in the same issue of NEJM.

See the article here:
Progesterone offers no significant benefit in traumatic brain injury clinical trial