Trial record 1 of 1 for:    NCT01143064
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Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury (SyNAPSe)

This study has been completed.
Sponsor:
Collaborators:
PRA Health Sciences
INC Research
Information provided by (Responsible Party):
BHR Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01143064
First received: June 10, 2010
Last updated: June 11, 2014
Last verified: June 2014

June 10, 2010
June 11, 2014
June 2010
March 2014   (final data collection date for primary outcome measure)
Glasgow Outcome Scale (GOS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Glasgow Outcome Scale (GOS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The GOS (Jennett and Bond, 1975) assesses mortality and disability in TBI patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.
Complete list of historical versions of study NCT01143064 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: 1 month and 6 months post injury ] [ Designated as safety issue: Yes ]
    The mortality rate at one and six months will be compared between the two treatment groups.
  • Glasgow Outcome Scale [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Glasgow Outcome Scale - Extended (GOS-E) [ Time Frame: 3 months and 6 months post injury ] [ Designated as safety issue: No ]

    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
  • Short Form (36) Health Survey (SF-36) [ Time Frame: 3 months and 6 months post injury ] [ Designated as safety issue: No ]

    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.

  • Effect of progesterone on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL) [ Time Frame: Admission through post-infusion Day 6 ] [ Designated as safety issue: No ]
  • Effect of progesterone on the progression of intracranial pathology [ Time Frame: Admission and Day 6 computed tomography (CT) scans ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Brain Injuries
  • 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
  • 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.
  • Active Comparator: Progesterone
    Intervention: Drug: Progesterone
  • Placebo Comparator: Lipid emulsion without progestrone
    Intervention: Drug: Lipid emulsion without progesterone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1195
March 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Germany,   France,   Israel,   China,   Thailand,   Czech Republic,   Hungary,   Argentina,   Spain,   Malaysia,   Austria,   United Kingdom,   Singapore,   Taiwan,   Russian Federation,   Romania,   Finland,   Belgium,   Netherlands
 
NCT01143064
BHR-100-301, 2010-018283-16
Yes
BHR Pharma, LLC
BHR Pharma, LLC
  • PRA Health Sciences
  • INC Research
Study Director: Neta R. Nelson, MPH BHR Pharma, LLC
BHR Pharma, LLC
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP