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 will evaluate the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe traumatic brain injury (TBI) patients.

Approximately 1,200 patients with severe (Glasgow Coma Scale scores of 4-8), closed-head trauma TBI will be enrolled in the study through more than 100 medical centers. Sites are located in the United States, Latin America, Europe, Israel, and Asia.

Patients are randomized to receive a five-day/120-hour, continuous intravenous infusion of progesterone or placebo in a 1:1 allocation. BHR-100 is a ready-to-use infusion designed to meet all U.S. Food and Drug Administration approval requirements, and as such is unlike intravenous progesterone infusions described in the medical literature. The study treatment must begin within 8 hours after injury.

Patients are followed for 6 months, 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 is the Contract Research Organization for the trial.