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Emory researchers announce Phase III study of progesterone for traumatic brain injury
Date:6/23/2009

Emory University officials this week announced the third phase of a groundbreaking study to evaluate the effectiveness of the hormone progesterone on acute traumatic-brain-injured patients.

Backed by a grant from the National Institutes of Health (NIH), the Emory-led, multicenter, randomized, double-blinded study (ProTECT III) will enroll 1,140 patients at 17 medical centers in 15 states. Atlanta's Grady Memorial Hospital will serve as the lead center, led by Emory University School of Medicine faculty researchers, in concert with colleagues from the Morehouse School of Medicine.

The initial award will be for three years and a total of approximately $14.5 million, in order to demonstrate target feasibility to conduct the trial. If milestones are met during the first three years, the trial could be extended for three more years with additional funding of approximately $14 million.

David Wright, MD, assistant professor of emergency medicine at Emory School of Medicine is the national study's lead investigator. Michael Frankel, MD, Emory professor of neurology, will serve as site principal investigator of the clinical trial at Grady. The University of Michigan will provide the central study oversight and coordination. Data analysis will occur at the Medical University of South Carolina.

Emory researchers concluded in an earlier clinical trial that giving progesterone to trauma victims shortly following brain injury appears to be safe and may reduce the risk of death and long-term disability. Their three-year study, called ProTECT (Progesterone for Traumatic brain injury--Experimental Clinical Treatment) enrolled 100 participants. It was designed to evaluate whether progesterone can be administered intravenously in a safe and reliable way.

"We found evidence that progesterone is not only safe for use in patients suffering from traumatic brain injuries showing no evidence of side effects or serious harmful events. We
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Contact: Lance Skelly
lance.skelly@emoryhealthcare.org
404-686-8538
Emory University
Source:Eurekalert

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