From the press release from Mission Health:
ASHEVILLE, N.C. – Mission Health today announced that researchers from its Trauma Services and Research Institute are participating in a global phase III, multi-center trial that tests progesterone infusion for the treatment of severe traumatic brain injury (TBI).
Known as the SyNAPSe® clinical trial, the study is evaluating the safety and effectiveness of an acute intravenous treatment, BHR-100, as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 3 to 8) TBI patients.
The Centers for Disease Control (CDC) has declared TBI as a serious public health problem in the United States, with 1.7 million people sustaining a traumatic brain injury each year. Brain injuries can happen to anyone and can bring a lifetime of physical, cognitive and behavioral challenges.
“Unfortunately, there are no proven treatments to prevent the long-term consequences of a TBI,” said William Shillinglaw, D.O., director of trauma services at Mission Health and principal investigator for the study. “Our researchers are building on promising results that suggest progesterone can improve outcomes for people who have sustained a TBI, with the intent of bringing an approved treatment to market.”
The SyNAPSe® clinical trial is the only phase III TBI trial designed for U.S. Food and Drug Administration (FDA) approval. The FDA has granted orphan drug status to BHR-100 and placed the drug on a Fast Track Development Program designed to accelerate its potential approval.
Previous clinical trials conducted in the U.S. and China suggest that progesterone can improve outcomes for people with a TBI. Both studies showed about a 50 percent lower mortality rate in the progesterone-treated group as compared to placebo. The Chinese study also showed a statistically significant improvement in patient function, and the U.S. study showed a similar trend.
Mission Health’s flagship hospital, Mission Hospital, is a North Carolina-designated Level II Trauma Center that includes neuro-trauma intensive care unit and the largest emergency department in the region, serving more than 100,000 patients a year. Patients with life- and limb-threatening injuries are met by an organized, highly-trained, multidisciplinary team dedicated to each patient’s care. As western North Carolina’s only designated Level II Trauma Center, it is staffed 24 hours a day to serve the region’s residents and visitors.
A major component of Mission Hospital’s system of care is working closely with community hospitals, first responders and EMS who evaluate, stabilize and prepare major trauma victims for transport to Mission Hospital. Utilizing Mission’s regional transport system’s ground transportation units and two helicopters, these critical patients have access to the specialized care they need. More information about Mission’s Level II Trauma Center and emergency services is available at www.missionhospitals.org/trauma.
Mission Hospital’s Research Institute conducts and supports a variety of research studies to keep Mission at the forefront of medical care and encourage the advancement of science through evidence-based medicine. The goal of the Research Institute is to discover and share knowledge gained through clinical research that will improve the health of all people. More information on the Research Institute can be found at www.missionhospitals.org/OurResearchFacility.
The SyNAPSe® clinical trial is sponsored by BHR Pharma, LLC. There are more than 140 trauma centers in 18 countries participating in SyNAPSe® led by the top brain injury experts in the world. For more information about the clinical trial, visit www.synapse-trial.com
About Mission Health
Mission Health, based in Asheville, NC, is the state’s sixth largest health system and the tertiary care regional referral center for Western NC and the adjoining region. In 2012, Mission Health was named by Thomson Reuters as one of the top 15 health systems in the nation – the only health system in North Carolina to receive this recognition.
Founded in 1885, Mission Health is the region’s only not-for-profit, independent community hospital system governed and managed exclusively in Western North Carolina. Mission operates five hospitals, numerous out-patient and surgery centers, and the region’s only dedicated Level II trauma center. Its medical staff consists of more than 750 physicians, and is certified in over 50 medical specialties and sub-specialties. Centers of excellence include heart, stroke care and neurosciences, and pediatrics. Mission Hospital, the system’s flagship hospital, is licensed for 730 beds and is the busiest surgical hospital in North Carolina. Other Mission hospitals include Blue Ridge Regional Hospital in Spruce Pine, McDowell Hospital in Marion, and Mission Children’s Hospital in Asheville. With approximately 8,800 employees and 700 volunteers, Mission Health is dedicated solely to serving and improving the health and wellness of the people of Western North Carolina.