NCT01143064

Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,195 (actual)
• Sponsor: BHR Pharma, LLC · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

Conditions

• Brain Injuries

Interventions

Type	Name	Description
DRUG	Progesterone	Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
DRUG	Lipid emulsion without progesterone	Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-06-14
• Last updated: 2024-10-02
• Results posted: 2024-10-02

Locations

156 sites across 21 countries: United States, Argentina, Austria, Belgium, China, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Malaysia, Netherlands, Romania, Russia, Singapore, Spain, Taiwan, Thailand, United Kingdom