SyNAPSe: A Randomized Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Progesterone in Patients with Severe Traumatic Brain Injury
BHR is conducting SyNAPSe® (Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brain Injuries), a global, Phase 3, multi-center pivotal trial in severe TBI. The study is evaluating the effectiveness of its proprietary BHR-100 progesterone product as a neuroprotective agent for the acute treatment of severe traumatic brain injury (TBI) patients.
Approximately 1,200 patients with severe (Glasgow Coma Scale scores of 3-8), closed-head TBI will be enrolled in the study at more than 150 medical centers. Sites are located in the United States, Argentina, Europe, Israel, and Asia.
Patients are randomized in a one-to-one allocation to receive progesterone or placebo. The treatment is admnistered as a five-day/120-hour, continuous intravenous infusion. BHR-100 is a ready-to-use formulation, built on patented technology, designed to meet all U.S. Food and Drug Administration approval requirements, unlike intravenous progesterone infusions described elsewhere in the medical literature. The study treatment must begin within eight hours after injury.
Patients are followed for six months post injury, at which point they will be evaluated using the Glasgow Outcome Scale (GOS) - the primary study endpoint. The clinical benefit of BHR-100 treatment is further assessed through the following secondary endpoints:
- Mortality at 1 month and 6 months post injury
- GOS at 3 months
- GOS-E at 3 and 6 months
- Quality of Life using Short Form (36) Health Survey (SF-36) at 3 and 6 months
- The effect on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL)
- The effect on the progression of intracranial pathology as assessed by admission and Day 6 computed tomography (CT) scans
The SyNAPSe study is endorsed by the American Brain Injury Consortium (ABIC) and the European Brain Injury Consortium (EBIC).
BHR collaborated with ABIC and EBIC on the design of the clinical study and to identify the trial sites. PRA International and INC Research are the Contract Research Organizations for the trial.