SyNAPSe - A Phase 3 Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brain Injuries Sponsored by BHR Pharma, LLC
Traumatic brain injury (TBI) is a major cause of death and disability worldwide. Among TBI victims the injuries result from automobile crashes, sports accidents, assaults and injuries sustained on the battlefield. Progesterone is a hormone primarily known for its role in pregnancy. Previous clinical trials have shown that progesterone has neuroprotective properties for both males and females. In June 2010, BHR Pharma, LLC, a U.S.-based research and development company, initiated SyNAPSe, a global, Phase 3, multi-center pivotal trial to evaluate the effectiveness of BHR-100, a proprietary progesterone formulation, in treating severe TBI.
For Clinicians
Traumatic brain injury (TBI) is a major cause of death and disability worldwide. Currently there are no approved medications to improve patient outcomes.
Why Progesterone
More than a sex hormone, progesterone has been shown in several clinical trials to have significant neuroprotective properties that can be instrumental in improving TBI outcomes.
About the Study
The BHR Pharma SyNAPSe Study will build on the promising results achieved in previous clinical trials by further investigating the safety and efficacy of progesterone as a treatment for severe TBI patients.
