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: Closed for enrollment.

For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.

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