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

NCT01143064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1195

Last updated 2024-10-02

Study results available
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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

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.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • BHR Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Neta R. Nelson, MPH · BHR Pharma, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • China
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Romania
  • Russia
  • Singapore
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143064 on ClinicalTrials.gov