Researchers at 17 medical centers across the US soon will begin using the hormone progesterone to treat patients who experience traumatic brain injury (TBI).
The treatment is part of a randomized, double-blind Phase III clinical trial that will enroll approximately 1,140 people over a three- to six-year period beginning in March, 2010.
The trial is funded by a grant to Emory University from the National Institutes of Health.
The clinical trial is led by David Wright, MD, associate professor of emergency medicine at Emory University School of Medicine. Atlanta’s Grady Memorial Hospital will serve as the lead center, with faculty from Emory School of Medicine and Morehouse School of Medicine.
Emory researchers concluded in an earlier three-year clinical trial conducted in 100 patients that giving progesterone to trauma victims shortly after a brain injury appears to be safe and may reduce the risk of death and long-term disability. That clinical trial was called ProTECT I (Progesterone for Traumatic brain injury ? Experimental Clinical Treatment). The current trial is named ProTECT III.
The earlier trial found evidence that progesterone is safe for use in patients suffering from traumatic brain injuries. Results also showed a 50 percent reduction in mortality in those patients treated with progesterone. The treatment improved functional outcomes and reduced disability in patients with moderate brain injury.
Progesterone is naturally present in small but measurable amounts in the brains of males and females. Human brain tissue is loaded with progesterone receptors. Laboratory studies suggest that progesterone is critical for the normal development of neurons in the brain and exerts protective effects on damaged brain tissue.
Donald G. Stein, PhD, Asa G. Candler Professor of Emergency Medicine, Emory School of Medicine, and director of Emory’s Department of Emergency Medicine Brain Research Laboratory, pioneered discoveries regarding the effect of progesterone following traumatic brain injury ? first discovering the neuro-protective properties of progesterone in the laboratory more than 25 years ago.
Every 15 seconds, someone in the United States sustains a significant traumatic brain injury. Approximately 2 million adults and children in the United States suffer from traumatic brain injuries each year – leading to 50,000 deaths and 80,000 new cases of long-term disability, according to the Centers for Disease Control and Prevention. Despite the enormity of the problem, scientists have failed to identify effective medications to improve outcomes following a traumatic brain injury.
“No new treatment for severe TBI has been approved in over 30 years,” says Wright. “With such promising success in laboratory testing and in our previous clinical trial, we hope to conclude in this national trial that progesterone?along with standard medical trauma care?works better than standard medical care alone in reducing brain damage caused from a TBI.”
Source: Emory University, USA