BHR Pharma, LLC (BHR) announced today that it will initiate a global, Phase 3, multi-center pivotal trial (www.synapse-trial.com) to evaluate the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe traumatic brain injury (TBI) patients in early 2010.
BHR will enroll approximately 1,200 patients with severe (Glasgow Coma Scale scores of 4-8), closed-head trauma TBI at 100-120 medical centers in the United States, Europe, Israel and additional countries.
Randomized patients will receive a five-day (120-hour) intravenous infusion of progesterone or placebo. Unlike intravenous progesterone infusions described in the medical literature, BHR-100 is a ready-to-use infusion designed to meet all U.S. Food and Drug Administration approval requirements.
BHR is collaborating with the American Brain Injury Consortium (ABIC) and the European Brain Injury Consortium (EBIC) to identify the trial sites and help design the clinical study. PRA International is the Contract Research Organization for the trial.
TBI is a non-degenerative, non-congenital insult to the brain from an external mechanical force, possibly leading to permanent or temporary impairments of cognitive, physical and psychosocial functions with an associated diminished or altered state of consciousness.