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

Sponsor
BHR Pharma, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01143064
Collaborator
PRA Health Sciences (Industry), Syneos Health (Other)
1,195
Enrollment
156
Locations
2
Arms
45
Duration (Months)
7.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 1, 2010
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Glasgow Outcome Scale (GOS) [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 [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 [Month 3]

    3. Glasgow Outcome Scale - Extended (GOS-E) [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) [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) [Admission through post-infusion Day 6]

    6. Effect of progesterone on the progression of intracranial pathology [Admission and Day 6 computed tomography (CT) scans]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Medical Center Mobile Alabama United States 36617
    2 LAC+USC Medical Center Los Angeles California United States 90033
    3 University of California San Diego Medical Center San Diego California United States 92103
    4 Denver Health Medical Center Denver Colorado United States 80204
    5 Christiana Care Health System Hospital Newark Delaware United States 19718
    6 Delray Medical Center Delray Beach Florida United States 33431
    7 Tallahassee Memorial Healthcare Tallahassee Florida United States 32308
    8 Tampa General Hospital Tampa Florida United States 33606
    9 Saint Alphonsus Regional Medical Center Boise Idaho United States 83706
    10 John H. Stroger Jr. Hospital of Cook County Chicago Illinois United States 60612
    11 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    12 Saint John's Hospital Springfield Illinois United States 62769
    13 Wishard Health Services Indianapolis Indiana United States 46202
    14 Methodist Hospital Indianapolis Indiana United States 46206
    15 Mercy Medical Center Des Moines Iowa United States 50314
    16 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    17 University of Kansas Medical Center Kansas City Kansas United States 66160
    18 University of Louisville Hospital Louisville Kentucky United States 40202
    19 LSU Health - Shreveport Shreveport Louisiana United States 71103
    20 Eastern Maine Medical Center Bangor Maine United States 04401
    21 Maine Medical Center Portland Maine United States 04102
    22 Baystate Medical Center Springfield Massachusetts United States 01199
    23 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    24 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    25 St. Mary's of Michigan Saginaw Michigan United States 48604
    26 University of Missouri Health Care Columbia Missouri United States 65212
    27 Truman Medical Center Hospital Hill Kansas City Missouri United States 64108
    28 Lester E. Cox Memorial Hospital Springfield Missouri United States 65804
    29 The Nebraska Medical Center Omaha Nebraska United States 68198
    30 Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    31 Albany Medical Center Hospital Albany New York United States 12208
    32 Westchester Medical Center Valhalla New York United States 10595
    33 Mission Hospital Asheville North Carolina United States 28801
    34 Carolinas Medical Center Charlotte North Carolina United States 28203
    35 Duke University Medical Center Durham North Carolina United States 27710
    36 Wake Forest University-Baptist Medical Center Winston-Salem North Carolina United States 27157
    37 Summa Health System Akron Ohio United States 44304
    38 MetroHealth Medical Center Cleveland Ohio United States 44109
    39 Miami Valley Hospital Dayton Ohio United States 45409
    40 St. Elizabeth Health Center Youngstown Ohio United States 44501
    41 OU Medical Center Oklahoma City Oklahoma United States 73104
    42 Legacy Emanuel Hospital & Health Center Portland Oregon United States 97227
    43 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    44 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    45 Medical University of South Carolina Charleston South Carolina United States 29425
    46 University of South Carolina School of Medicine Columbia South Carolina United States 29203
    47 Johnson City Medical Center Johnson City Tennessee United States 37604
    48 Vanderbilt University Medical Center Nashville Tennessee United States 37212
    49 Texas Tech University Health Sciences Center El Paso Texas United States 79905
    50 University of Virginia Health System Charlottesville Virginia United States 22908
    51 Marshall University Joan C. Edwards School of Medicine Huntington West Virginia United States 25701
    52 West Virginia University Hospital Morgantown West Virginia United States 26506
    53 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    54 Hospital Francisco Lopez Lima General Roca Rio Negro Argentina
    55 Hospital de Emergencias Clemente Alvarez (HECA) Rosario Santa Fe Argentina
    56 Hospital Central de Mendoza Mendoza Argentina
    57 Hospital San Martin Paraná Argentina
    58 Hospital Nacional "Profesor Alejandro Posadas" Provincia de Buenos Aires Argentina
    59 Hospital Regional De Comodoro Rivadavia (HRCR) Provincia de Chubut Argentina
    60 Hospital Dr. José Maria Cullen Santa Fé Argentina
    61 Medizinische Universität Graz Graz Austria
    62 Medizinische Universität Innsbruck Innsbruck Austria
    63 Unfallkrankenhaus Salzburg Salzburg Austria
    64 Landesklinikum Wiener Neustadt Vienna Austria
    65 ULB Erasme Brussels Belgium
    66 Ziekenhuis Oost-Limburg, Location Sint Jan Genk Belgium
    67 Universitair Ziekenhuis Gent Gent Belgium
    68 University Hospital of the Free University Brussels (UZ Brussel) Jette Belgium
    69 University Hospital Gasthuisberg Leuven Belgium
    70 Chengdu Military General Hospital Chengdu China
    71 The First Affiliated Hospital of Fujian Medical University Fuzhou China
    72 The 2nd Affiliated Hospital of Zhejiang University Hangzhou China
    73 The Second Hospital of Shandong University Jinan China
    74 Huashan Hospital of Fudan University Shanghai China
    75 Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China
    76 General Hospital of Tianjin Medical University Tianjin China
    77 The Affiliated Hospital of Xuzhou Medical College Xuzhou China
    78 Fakultní nemocnice Brno Neurochirurgická klinika Brno Czech Republic
    79 Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika Brno Czech Republic
    80 Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení Plzeň Czech Republic
    81 Fakultní nemocnice Kralovske Vinohrady Praha Czech Republic
    82 Tampere University Hospital Tampere Finland
    83 Groupe Hospitalier Pellegrin Bordeaux France
    84 Hôpital Pierre Wertheimer Bron France
    85 Centre Hospitalier Universitaire de Grenoble- Hópital Michallon La Tronche France
    86 CHRU de Lille- Hópital Roger Salengro Lille France
    87 Centre Hospitalier Universitaire de Limoges Limoges France
    88 Centre Hospitalier Universitaire Hôpital Nord Marseille France
    89 Hópital Central - CHU de Nancy Nancy France
    90 Groupe Hospitalier La Salpêtrière Paris France
    91 Charité - Universitätsmedizin Berlin Berlin Germany
    92 Klinikum der J.W. Goethe-Universität Frankfurt Germany
    93 Universitätsmedizin Göttingen Göttingen Germany
    94 Berufsgenossenschaftliche Kliniken Halle Germany
    95 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany
    96 Universitätsklinikum Heidelberg Heidelberg Germany
    97 Krankenhaus Merheim Köln Germany
    98 Universitätsklinikum Gießen und Marburg gGmbH Marburg Germany
    99 Klinikum Nürnberg Nürnberg Germany
    100 Niels-Stensen-Kliniken Osnabrück Germany
    101 Universitätsklinikum Ulm Ulm Germany
    102 Honvédelmi Minisztérium Állami Egészségügyi Központ Budapest Hungary
    103 Pécsi Tudományegyetem Általános Orvostudományi Kar Pécs Hungary
    104 Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged Hungary
    105 Rambam Medical Center Haifa Israel
    106 Hadassah Medical Organization Jerusalem Israel
    107 Rabin Medical Center Petach-Tikva Israel
    108 Tel Aviv Sourasky Medical Center Tel Aviv Israel
    109 Chaim Sheba Medical Center Tel-Hashomer Israel
    110 Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Milano Italy
    111 Fondazione San Raffaele del Monte Tabor Milano Italy
    112 Azienda Ospedaliera San Gerardo Monza Italy
    113 Azienda Ospedaliero Universitaria Maggiore della Caritá Novara Italy
    114 Azienda Ospedaliera San Camillo Forlanini Rome Italy
    115 Azienda Ospedaliero Universitaria Integrata di Verona Verona Italy
    116 Hospital Raja Permaisuri Bainun Ipoh, Perak Malaysia
    117 Hospital Kuala Lumpur Kuala Lumpur Malaysia
    118 University Malaya Medical Centre Kuala Lumpur Malaysia
    119 Hospital Tengku Ampuan Afzan Kuantan, Pahang Malaysia
    120 Sarawak General Hospital Kuching, Sarawak Malaysia
    121 VU Medisch Centrum Amsterdam Netherlands
    122 Universitair Medisch Centrum Groningen Groningen Netherlands
    123 Spitalul Clinic Judetean de Urgenta Timisoara Timisoara Romania
    124 State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development" Kemerovo Russian Federation
    125 State Professional Institution of High Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development" Krasnoyarsk Russian Federation
    126 State Institution "Burdenko Neurosurgical Institute of RAMS" Moscow Russian Federation
    127 State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin" Murmansk Russian Federation
    128 Saint Petersburg Healthcare Institution "City Mariinsky Hospital" St. Petersburg Russian Federation
    129 State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1" Yekaterinburg Russian Federation
    130 National Neuroscience Institute Singapore Singapore
    131 National University Hospital Singapore Singapore
    132 Singapore General Hospital Singapore Singapore
    133 Hospital Universitario Germans Trias i Pujol Badalona Barcelona Spain
    134 Hospital Parc Taulí Sabadell Barcelona Spain
    135 Hospital General Universitario de Alicante Alicante Spain
    136 Hospital Universitario de Bellvitge Barcelona Spain
    137 Hospital Universitario Vall Hebrón Barcelona Spain
    138 Hospital Universitario de Girona Dr. Josep Trueta Girona Spain
    139 Hospital Universitario de Gran Canaria Dr. Negrín Las Palmas de Gran Canaria Spain
    140 Hospital Universitario 12 de Octubre Madrid Spain
    141 Hospital Universitari Son Espases Palma de Mallorca Spain
    142 Hospital Universitario Virgen del Rocio Sevilla Spain
    143 Hospital Clínico Universitario De Valencia Valencia Spain
    144 Hospital Universitari i Politecnic La Fé de Valencia Valencia Spain
    145 Taichung Veterans General Hospital Taichung Taiwan
    146 National Taiwan University Hospital Taipei Taiwan
    147 Chiang Mai University Chiang Mai Thailand
    148 Faculty of Medicine, Prince of Songkla University Hat yai Thailand
    149 Khon Kaen Hospital Khon Kaen Thailand
    150 Royal Preston Hospital Fulwood Preston United Kingdom
    151 Queen Elizabeth Hospital Birmingham United Kingdom
    152 University Hospital Coventry Coventry United Kingdom
    153 Leeds Teaching Hospitals NHS, Leeds General Infirmary Leeds United Kingdom
    154 The Royal London Hospital London United Kingdom
    155 The James Cook University Hospital Middlesbrough United Kingdom
    156 Southampton University Hospital Southampton United Kingdom

    Sponsors and Collaborators

    • BHR Pharma, LLC
    • PRA Health Sciences
    • Syneos Health

    Investigators

    • Study Director: Neta R. Nelson, MPH, BHR Pharma, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    BHR Pharma, LLC
    ClinicalTrials.gov Identifier:
    NCT01143064
    Other Study ID Numbers:
    • BHR-100-301
    • 2010-018283-16
    First Posted:
    Jun 14, 2010
    Last Update Posted:
    Jun 19, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by BHR Pharma, LLC
    Brain Injury
    Trauma
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries
    Progesterone

    Study Results

    No Results Posted as of Jun 19, 2014