Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury (SyNAPSe)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01143064|
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : June 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||Drug: Progesterone Drug: Lipid emulsion without progesterone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1195 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|Active Comparator: Progesterone||
Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Other Name: BHR-100
|Placebo Comparator: Lipid emulsion without progestrone||
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.
- Glasgow Outcome Scale (GOS) [ Time Frame: 6 months ]The GOS (Jennett and Bond, 1975) assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.
- Mortality [ Time Frame: 1 month and 6 months post injury ]The mortality rate at one and six months will be compared between the two treatment groups.
- Glasgow Outcome Scale [ Time Frame: Month 3 ]
- Glasgow Outcome Scale - Extended (GOS-E) [ Time Frame: 3 months and 6 months post injury ]
The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories:
- Vegetative State
- Lower Severe Disability
- Upper Severe Disability
- Lower Moderate Disability
- Upper Moderate Disability
- Lower Good Recovery
- Upper Good Recovery
- Short Form (36) Health Survey (SF-36) [ Time Frame: 3 months and 6 months post injury ]
The SF-36 is a validated survey of patient health consisting of eight scaled scores. The eight sections are:
- physical functioning
- bodily pain
- general health perceptions
- role physical
- role emotional
- role mental
- mental health
The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health.
- Effect of progesterone on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL) [ Time Frame: Admission through post-infusion Day 6 ]
- Effect of progesterone on the progression of intracranial pathology [ Time Frame: Admission and Day 6 computed tomography (CT) scans ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143064
|Study Director:||Neta R. Nelson, MPH||BHR Pharma, LLC|