SyNAPSe Clinical Trial

Title: “A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients with Severe Traumatic Brain Injury”

Study Sponsor: BHR Pharma, LLC

Principal Investigator: Christopher Rumana, MD

Study Synopsis: The aim of the study is to determine the efficacy and safety of BHR-100 I.V. progesterone infusion compared to placebo infusion utilizing the Glascow Outcome Scale in patients with severe traumatic brain injury (GCS 4-8).

Patients enrolled in the trial will be randomized to receive either BHR-100 progesterone continuous infusion or Placebo continuous infusion for a total of 5 days post-injury. All study subjects will undergo clinical evaluation for up to 15 days during hospitalization and at 1 month, 3 months, and 6 months. This study will enroll a total of 1180 patients and be conducted in approximately 100 sites in North America, Europe, Asia, and South America.

Study Status: Open for enrollment. Who qualifies? Patients are typically enrolled in the emergency room and may qualify if their traumatic brain injury meets the study criteria.

For more information, contact by e-mail April Bell, MS, CCRC at abelltnc-neurocom  (abelltnc-neurocom)  , or contact her by phone at 850-558-1230.