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

Brain Injuries Clinical Trial

Official 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01143064
Study type Interventional
Source BHR Pharma, LLC
Contact
Status Completed
Phase Phase 3
Start date June 2010
Completion date March 2014
View Details
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