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.
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