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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
Sponsor:
Collaborators:
PRA Health Sciences
Syneos Health
Information provided by (Responsible Party):
BHR Pharma, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Brain Injuries Drug: Progesterone Drug: Lipid emulsion without progesterone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Progesterone Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Glasgow Outcome Scale [ Time Frame: Month 3 ]
  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:

    • Dead
    • Vegetative State
    • Lower Severe Disability
    • Upper Severe Disability
    • Lower Moderate Disability
    • Upper Moderate Disability
    • Lower Good Recovery
    • Upper Good Recovery

  4. 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:

    • vitality
    • 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.


  5. Effect of progesterone on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL) [ Time Frame: Admission through post-infusion Day 6 ]
  6. Effect of progesterone on the progression of intracranial pathology [ Time Frame: Admission and Day 6 computed tomography (CT) scans ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients between the age of 16 and 70 years, inclusive
  2. Weight from 45 to 135 kg, inclusive
  3. Sustained a closed head trauma no more than 8 hours before start of study drug infusion
  4. TBI diagnosed by history and clinical examination
  5. Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
  6. At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
  7. Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
  8. Indication for ICP monitoring

Exclusion Criteria:

  1. Life expectancy of less than 24 hours as determined by the Investigator
  2. Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of randomization
  3. Any spinal cord injury
  4. Pregnancy
  5. Penetrating head injury
  6. Bilaterally fixed dilated pupils at the time of randomization
  7. Coma suspected to be primarily due to other causes (e.g. alcohol)
  8. Pure epidural hematoma
  9. Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
  10. Severe cardiac or hemodynamic instability prior to randomization
  11. Known treatment with another investigational drug therapy or procedure within 30 days of injury
  12. A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
  13. Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
  14. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
BHR Pharma, LLC
PRA Health Sciences
Syneos Health
Investigators
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Study Director: Neta R. Nelson, MPH BHR Pharma, LLC
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: BHR Pharma, LLC
ClinicalTrials.gov Identifier: NCT01143064    
Other Study ID Numbers: BHR-100-301
2010-018283-16 ( EudraCT Number )
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014
Keywords provided by BHR Pharma, LLC:
Brain Injury
Trauma
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
 Trauma, Nervous System
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs