HERNDON, Va., July 23 /PRNewswire-USNewswire/ -- BHR Pharma, LLC (BHR) announced today that the first patient has been enrolled in its SyNAPSe study (www.synapse-trial.com), a global, Phase 3, pivotal trial to evaluate the safety and effectiveness of its intravenous progesterone infusion product (BHR-100) as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 4-8) traumatic brain injury (TBI) patients.
The study will randomize approximately 1,200 patients at more than 100 sites to receive a five-day (120-hour) continuous intravenous infusion of progesterone or placebo. The study protocol requires that treatment begin within eight hours of injury. Patients will be followed for six months post-injury.
The first patient was enrolled at the University of Pittsburgh Medical Center in Pittsburgh, PA.
TBI is a non-degenerative, non-congenital insult to the brain from an external mechanical force, such as a car accident, a fall or an explosion. The injury can lead to permanent or temporary impairments of cognitive, physical and psychosocial functions with an associated diminished or altered state of consciousness. An estimated 1.7 million Americans per year suffer a TBI, resulting in 52,000 deaths, 275,000 hospitalizations and 80,000 cases of long-term disability.