Editor: Roland Torres, MD, FAANS, FACS Spring 2012  
In this Issue...
Message from the Chair
Neurotrauma and Critical Care Web Page Update
Sports Medicine Committee
Clinical Research Update:
ProTECT III
When the Cameras All Are On You
  Clinical Research Update: ProTECT III

Roland Torres, MD; and David Wright, MD

Traumatic Brain Injury (TBI) is a significant cause of death and disability worldwide. An estimated 5.3 million Americans (a little more than two percent of the U.S population) currently live with disabilities resulting from brain injury. From 1995 to 2001, nearly two million TBIs occurred in the U.S. each year. Of these, most (70 percent) were emergency department visits, followed by hospitalizations (34 percent) and deaths (3.8 percent).This does not include private-physician office visits, "Doc-in-the-Box," etc.

Yet despite the enormity of the problem presently, we still have no therapeutic agent that improves outcome for our TBI patients. Few drugs have shown promise to treat TBI, and over the past 30 years, all the clinical trials involving therapeutic agents for TBI have failed, with at least two studies halted when the drugs made patients ill. Recently, in a 100-person trial at an Atlanta hospital between 2001 and 2005, TBI patients given progesterone were more than twice as likely to survive as those given a placebo. Patients with moderate brain injuries were more likely to recover if given progesterone. Progesterone has well-understood and limited side effects.

Currently, an impressive body of evidence suggests that progesterone, a neurosteroid more commonly known for its actions in the female menstrual cycle and pregnancy, is neuroprotective. There now are more than 180 preclinical publications reporting the positive effect of progesterone on a wide variety on neuronal injury. In addition, there are two human pilot trials — one that shows a trend toward reduced death and disability (Wright et al.) and another that confirms a significant improvement in progesterone-treated acute TBI patients (Xiou et al.).

The The ProTECT III trial is a phase III multicenter clinical trial designed to definitely determine if progesterone is neuroprotective in acute TBI. The National Institute of Neurological Disorders and Stroke- (NINDS) and National Institutes of Health- (NIH) funded trial is being conducted through the Neurological Emergencies Treatment Trials network. ProTECT III officially opened for enrollment on March 22, 2010, with the first patient enrollment on April 5, 2010. Since this time, 22 sites have been activated; 394 out of the total goal of 1,140 subjects have been enrolled into the trial so far. The trial is exceeding enrollment expectations and meeting all predetermined milestones. Going forward, enrollment is expected to average 24 subjects per month, which would equate to three more years of enrollment. If the trial is positive, progesterone would represent the first real pharmacological treatment to improve functional outcome in acute TBI patients, dramatically changing the lives of patients and their families.

Neuroscientists say this trial to find a drug that can treat traumatic brain injury is the most promising in decades. TBI afflicts one to two million Americans each year, with the cost of long-term care reaching $80 billion annually.


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