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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
  Purpose

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 Intervention Phase
Brain Injuries
Drug: Progesterone
Drug: Lipid emulsion without progesterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by BHR Pharma, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1195
Study Start Date: June 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143064

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, California
LAC+USC Medical Center
Los Angeles, California, United States, 90033
University of California San Diego Medical Center
San Diego, California, United States, 92103
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Delaware
Christiana Care Health System Hospital
Newark, Delaware, United States, 19718
United States, Florida
Delray Medical Center
Delray Beach, Florida, United States, 33431
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32308
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Saint John's Hospital
Springfield, Illinois, United States, 62769
United States, Indiana
Wishard Health Services
Indianapolis, Indiana, United States, 46202
Methodist Hospital
Indianapolis, Indiana, United States, 46206
United States, Iowa
Mercy Medical Center
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
LSU Health - Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
St. Mary's of Michigan
Saginaw, Michigan, United States, 48604
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Truman Medical Center Hospital Hill
Kansas City, Missouri, United States, 64108
Lester E. Cox Memorial Hospital
Springfield, Missouri, United States, 65804
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
Westchester Medical Center
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University-Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Miami Valley Hospital
Dayton, Ohio, United States, 45409
St. Elizabeth Health Center
Youngstown, Ohio, United States, 44501
United States, Oklahoma
OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Hospital & Health Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina School of Medicine
Columbia, South Carolina, United States, 29203
United States, Tennessee
Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, West Virginia
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, United States, 25701
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Argentina
Hospital Francisco Lopez Lima
General Roca, Rio Negro, Argentina
Hospital de Emergencias Clemente Alvarez (HECA)
Rosario, Santa Fe, Argentina
Hospital Central de Mendoza
Mendoza, Argentina
Hospital San Martin
Paraná, Argentina
Hospital Nacional "Profesor Alejandro Posadas"
Provincia de Buenos Aires, Argentina
Hospital Regional De Comodoro Rivadavia (HRCR)
Provincia de Chubut, Argentina
Hospital Dr. José Maria Cullen
Santa Fé, Argentina
Austria
Medizinische Universität Graz
Graz, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Unfallkrankenhaus Salzburg
Salzburg, Austria
Landesklinikum Wiener Neustadt
Vienna, Austria
Belgium
ULB Erasme
Brussels, Belgium
Ziekenhuis Oost-Limburg, Location Sint Jan
Genk, Belgium
Universitair Ziekenhuis Gent
Gent, Belgium
University Hospital of the Free University Brussels (UZ Brussel)
Jette, Belgium
University Hospital Gasthuisberg
Leuven, Belgium
China
Chengdu Military General Hospital
Chengdu, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
The 2nd Affiliated Hospital of Zhejiang University
Hangzhou, China
The Second Hospital of Shandong University
Jinan, China
Huashan Hospital of Fudan University
Shanghai, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
General Hospital of Tianjin Medical University
Tianjin, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China
Czech Republic
Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika
Brno, Czech Republic
Fakultní nemocnice Brno Neurochirurgická klinika
Brno, Czech Republic
Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení
Plzeň, Czech Republic
Fakultní nemocnice Kralovske Vinohrady
Praha, Czech Republic
Finland
Tampere University Hospital
Tampere, Finland
France
Groupe Hospitalier Pellegrin
Bordeaux, France
Hôpital Pierre Wertheimer
Bron, France
Centre Hospitalier Universitaire de Grenoble- Hópital Michallon
La Tronche, France
CHRU de Lille- Hópital Roger Salengro
Lille, France
Centre Hospitalier Universitaire de Limoges
Limoges, France
Centre Hospitalier Universitaire Hôpital Nord
Marseille, France
Hópital Central - CHU de Nancy
Nancy, France
Groupe Hospitalier La Salpêtrière
Paris, France
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Klinikum der J.W. Goethe-Universität
Frankfurt, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Berufsgenossenschaftliche Kliniken
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Krankenhaus Merheim
Köln, Germany
Universitätsklinikum Gießen und Marburg gGmbH
Marburg, Germany
Klinikum Nürnberg
Nürnberg, Germany
Niels-Stensen-Kliniken
Osnabrück, Germany
Universitätsklinikum Ulm
Ulm, Germany
Hungary
Honvédelmi Minisztérium Állami Egészségügyi Központ
Budapest, Hungary
Pécsi Tudományegyetem Általános Orvostudományi Kar
Pécs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary
Israel
Rambam Medical Center
Haifa, Israel
Hadassah Medical Organization
Jerusalem, Israel
Rabin Medical Center
Petach-Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Center
Tel-Hashomer, Israel
Italy
Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milano, Italy
Fondazione San Raffaele del Monte Tabor
Milano, Italy
Azienda Ospedaliera San Gerardo
Monza, Italy
Azienda Ospedaliero Universitaria Maggiore della Caritá
Novara, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Italy
Azienda Ospedaliero Universitaria Integrata di Verona
Verona, Italy
Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Netherlands
VU Medisch Centrum
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Romania
Spitalul Clinic Judetean de Urgenta Timisoara
Timisoara, Romania
Russian Federation
State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"
Kemerovo, Russian Federation
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
State Institution "Burdenko Neurosurgical Institute of RAMS"
Moscow, Russian Federation
State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"
Murmansk, Russian Federation
Saint Petersburg Healthcare Institution "City Mariinsky Hospital"
St. Petersburg, Russian Federation
State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"
Yekaterinburg, Russian Federation
Singapore
Singapore General Hospital
Singapore, Singapore
National Neuroscience Institute
Singapore, Singapore
National University Hospital
Singapore, Singapore
Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Universitario Vall Hebrón
Barcelona, Spain
Hospital Universitario de Girona Dr. Josep Trueta
Girona, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Hospital Clínico Universitario De Valencia
Valencia, Spain
Hospital Universitari i Politecnic La Fé de Valencia
Valencia, Spain
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Thailand
Chiang Mai University
Chiang Mai, Thailand
Faculty of Medicine, Prince of Songkla University
Hat yai, Thailand
Khon Kaen Hospital
Khon Kaen, Thailand
United Kingdom
Royal Preston Hospital
Fulwood, Preston, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Leeds Teaching Hospitals NHS, Leeds General Infirmary
Leeds, United Kingdom
The Royal London Hospital
London, United Kingdom
The James Cook University Hospital
Middlesbrough, United Kingdom
Southampton University Hospital
Southampton, United Kingdom
Sponsors and Collaborators
BHR Pharma, LLC
PRA Health Sciences
INC Research
Investigators
Study Director: Neta R. Nelson, MPH BHR Pharma, LLC
  More Information

Additional Information:
Publications:
Responsible Party: BHR Pharma, LLC
ClinicalTrials.gov Identifier: NCT01143064     History of Changes
Other Study ID Numbers: BHR-100-301, 2010-018283-16
Study First Received: June 10, 2010
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Malaysia: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Center for Drug Evaluation
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by BHR Pharma, LLC:
Brain Injury
Trauma

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on October 29, 2014