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A Study With SAGE-547 for Super-Refractory Status Epilepticus

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ClinicalTrials.gov Identifier: NCT02477618
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).

Condition or disease Intervention/treatment Phase
Super-Refractory Status Epilepticus Drug: SAGE-547 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus
Study Start Date : June 2015
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : August 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SAGE-547
Intravenous
Drug: SAGE-547
Placebo Comparator: Placebo
Intravenous
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Number of patients that are able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion, and remain off all third-line agents for ≥ 24 hours following the end of the SAGE-547 or placebo infusion [ Time Frame: 7 days ]


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects two (2) years of age and older
  • Subjects who have:

    • Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial anti-epileptic drug [AED] treatment), according to institution standard of care, and;
    • Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED), according to institution standard of care, and;
    • Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agent and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent but not in an EEG burst or seizure suppression pattern

Exclusion Criteria:

  • Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
  • Children (subjects aged less than 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder
  • Subjects who have any of the following:

    1. a glomerular filtration rate (GFR) low enough to warrant dialysis but for whatever reason, dialysis is not planned or non-continuous dialysis planned (that would not adequately remove Captisol®);
    2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
    3. fulminant hepatic failure;
    4. no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is less than 30 days.
  • Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol

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): NCT02477618


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Locations
United States, Alabama
Sage Investigational Site
Birmingham, Alabama, United States, 35233
Sage Investigational Site
Mobile, Alabama, United States, 36667
United States, Arizona
Sage Investigational Site
Phoenix, Arizona, United States, 85006
Sage Investigational Site
Phoenix, Arizona, United States, 85013
United States, Arkansas
Sage Investigational Site
Little Rock, Arkansas, United States, 27702
United States, California
Sage Investigational Site
Fresno, California, United States, 93721
Sage Investigational Site
Loma Linda, California, United States, 92354
Sage Investigational Site
Los Angeles, California, United States, 90027
Sage Investigational Site
Roseville, California, United States, 95661
Sage Investigational Site
Sacramento, California, United States, 95317
United States, Connecticut
Sage Investigational Site
New Haven, Connecticut, United States, 06510
United States, Delaware
Sage Investigational Site
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Sage Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Sage Investigational Site
Gainesville, Florida, United States, 32611
Sage Investigational Site
Jacksonville, Florida, United States, 32209
Sage Investigational Site
Miami, Florida, United States, 33155
Sage Investigational Site
Orlando, Florida, United States, 32803
Sage Investigational Site
Sarasota, Florida, United States, 34239
Sage Investigational Site
Tampa, Florida, United States, 33613
Sage Investigational Site
Weston, Florida, United States, 33331
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30303
Sage Investigational Site
Atlanta, Georgia, United States, 30322
Sage Investigational Site
Atlanta, Georgia, United States, 30342
United States, Hawaii
Sage Investigational Site
Honolulu, Hawaii, United States, 96813
Sage Investigational Site
Honolulu, Hawaii, United States, 96826
United States, Idaho
Sage Investigational Site
Boise, Idaho, United States, 83706
United States, Illinois
Sage Investigational Site
Chicago, Illinois, United States, 60611
Sage Investigational Site
Chicago, Illinois, United States, 60612
Sage Investigational Site
Maywood, Illinois, United States, 60153
Sage Investigational Site
Peoria, Illinois, United States, 61637
Sage Investigational Site
Springfield, Illinois, United States, 62702
Sage Investigational Site
Urbana, Illinois, United States, 61801
United States, Iowa
Sage Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kansas
Sage Investigational Site
Wichita, Kansas, United States, 67214
United States, Kentucky
Sage Investigational Site
Lexington, Kentucky, United States, 40536
Sage Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
Sage Investigational Site
Baton Rouge, Louisiana, United States, 70808
Sage Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Maine
Sage Investigational Site
Portland, Maine, United States, 04102
United States, Maryland
Sage Investigational Site
Baltimore, Maryland, United States, 21201
Sage Investigational Site
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Sage Investigational Site
Boston, Massachusetts, United States, 02111
Sage Investigational Site
Boston, Massachusetts, United States, 02114
Sage Investigational Site
Boston, Massachusetts, United States, 02115
Sage Investigational Site
Boston, Massachusetts, United States, 02118
Sage Investigational Site
Boston, Massachusetts, United States, 02215
Sage Investigational Site
Newton, Massachusetts, United States, 02462
United States, Michigan
Sage Investigational Site
Ann Arbor, Michigan, United States, 48109
Sage Investigational Site
Detroit, Michigan, United States, 48201
Sage Investigational Site
Detroit, Michigan, United States, 48202
Sage Investigational Site
East Lansing, Michigan, United States, 48824
Sage Investigational Site
Grand Rapids, Michigan, United States, 49503
Sage Investigational Site
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Sage Investigational Site
Minneapolis, Minnesota, United States, 55414
Sage Investigational Site
Rochester, Minnesota, United States, 55905
United States, Mississippi
Sage Investigational Site
Jackson, Mississippi, United States, 39216
United States, Missouri
Sage Investigational Site
Kansas City, Missouri, United States, 64108
Sage Investigational Site
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Sage Investigational Site
Edison, New Jersey, United States, 08818
Sage Investigational Site
Morristown, New Jersey, United States, 08827
Sage Investigational Site
New Brunswick, New Jersey, United States, 08901
Sage Investigational Site
Summit, New Jersey, United States, 07901
United States, New York
Sage Investigational Site
Buffalo, New York, United States, 14203
Sage Investigational Site
New York, New York, United States, 10016
Sage Investigational Site
New York, New York, United States, 10029
Sage Investigational Site
New York, New York, United States, 10032
Sage Investigational Site
Port Jefferson, New York, United States, 11777
Sage Investigational Site
Rochester, New York, United States, 14642
Sage Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
Sage Investigational Site
Durham, North Carolina, United States, 27710
Sage Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Sage Investigational Site
Akron, Ohio, United States, 44308
Sage Investigational Site
Cincinnati, Ohio, United States, 45229
Sage Investigational Site
Cincinnati, Ohio, United States, 45267
Sage Investigational Site
Cleveland, Ohio, United States, 44195
Sage Investigational Site
Columbus, Ohio, United States, 43210
Sage Investigational Site
Toledo, Ohio, United States, 43614
United States, Oregon
Sage Investigational Site
Portland, Oregon, United States, 97213
Sage Investigational Site
Portland, Oregon, United States, 97225
Sage Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Sage Investigational Site
Hershey, Pennsylvania, United States, 17033
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19141
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19147
Sage Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Sage Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Sage Investigational Site
Memphis, Tennessee, United States, 38105
Sage Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
Sage Investigational Site
Austin, Texas, United States, 78723
Sage Investigational Site
Dallas, Texas, United States, 75251
Sage investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Sage Investigational Site
Salt Lake City, Utah, United States, 84108
Sage Investigational Site
Salt Lake City, Utah, United States, 84113
United States, Vermont
Sage Investigational Site
Burlington, Vermont, United States, 05401
United States, Washington
Sage Investigational Site
Seattle, Washington, United States, 98105
United States, West Virginia
Sage Investigational Site
Huntington, West Virginia, United States, 25705
Sage Investigational Site
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Sage Investigational Site
Wauwatosa, Wisconsin, United States, 53226
Austria
Sage Investigational Site
Innsbruck, Austria, 6020
Sage Investigational Site
Salzburg, Austria, 5020
Canada, British Columbia
Sage Investigational Site
Vancouver, British Columbia, Canada, V6H3V4
Canada, Ontario
Sage Investigational Site
Hamilton, Ontario, Canada, L8L 2X2
Sage Investigational Site
Kingston, Ontario, Canada, K7L3C9
Sage Investigational Site
London, Ontario, Canada, N6A5A5
Canada, Quebec
Sage Investigational Site
Montreal, Quebec, Canada, H1T 2M4
Sage Investigational Site
Montreal, Quebec, Canada, H2L 4M1
Sage Investigational Site
Montreal, Quebec, Canada, H3A 2B4
Sage Investigational Site
Montreal, Quebec, Canada, H3T1C5
Sage Investigational Site
Montréal, Quebec, Canada, H1T 2M4
Sage Investigational Site
Montréal, Quebec, Canada, H3T 1C5
Denmark
Sage Investigational Site
Copenhagen, Denmark, 2100
Estonia
Sage Investigational Site
Tallinn, Estonia, 10617
Sage Investigational Site
Tallinn, Estonia, 13419
Sage Investigational Site
Tartu, Estonia, 51014
Finland
Sage Investigational Site
Helsinki, Finland, 00029
Sage Investigational Site
Kuopio, Finland, 70210
France
Sage Investigational Site
Bron Cedex, France, 69677
Sage Investigational Site
Dijon, France, 21079
Sage Investigational Site
Lille, France, 59037
Sage Investigational Site
Limoges, France, 87042
Sage Investigational Site
Lyon, France, 69677
Sage Investigational Site
Paris, France, 75851
Germany
Sage Investigational Site
Hamburg, Germany, 22337
Sage Investigational Site
Marburg, Germany, 35043
Sage Investigational Site
Osnabruck, Germany, 49076
Hungary
Sage Investigational Site
Balassagyarmat, Hungary, 2660
Sage Investigational Site
Budapest, Hungary, 01134
Sage Investigational Site
Budapest, Hungary, 1134
Israel
Sage Investigational Site
Ashqelon, Israel, 7830604
Sage Investigational Site
Holon, Israel, 58100
Sage Investigational Site
Holon, Israel
Sage Investigational Site
Jerusalem, Israel, 91120
Sage Investigational Site
Petach Tikva, Israel, 49100
Sage Investigational Site
Tel Hashomer, Israel, 52621
Sage Investigational Site
Tzrifin, Israel, 70300
Italy
Sage Investigational Site
Bologna, Italy, 40139
Sage Investigational Site
Firenze, Italy, 50139
Sage Investigational Site
Florence, Italy, 50139
Sage Investigational Site
Milano, Italy, 20132
Sage Investigational Site
Milano, Italy, 20133
Sage Investigational Site
Milan, Italy, 20132
Sage Investigational Site
Modena, Italy, 41100
Sage Investigational Site
Modena, Italy, 41126
Sage Investigational Site
Monza, Italy, 20900
Sage Investigational Site
Perugia, Italy, 06129
Sage Investigational Site
Reggio Calabria, Italy, 89124
Sage Investigational Site
Rome, Italy, 00165
Sage Investigational Site
Rome, Italy, 165
Sage Investigational Site
Verona, Italy, 37126
Netherlands
Sage Investigational Site
Enschede, Netherlands, 7512KZ
Sage Investigational Site
Heerlen, Netherlands, 6419PC
Sage Investigational Site
Maastricht, Netherlands, 6202AZ
Sage Investigational Site
Nijmegen, Netherlands, 6525GA
Serbia
Sage Investigational Site
Belgrade, Serbia, 11000
Sage Investigational Site
Belgrade, Serbia, 11070
Sage Investigational Site
Nis, Serbia, 18000
Sage Investigational Site
Novi Sad, Serbia, 21000
Spain
Sage Investigational Site
Badalona, Spain, 8916
Sage Investigational Site
Barakaldo, Spain, 48903
Sage Investigational Site
Barcelona, Spain, 08035
Sage Investigational Site
Barcelona, Spain, 08036
Sage Investigational Site
Cordoba, Spain, 14004
Sage Investigational Site
Granada, Spain, 18016
Sage Investigational Site
Hospitalet de Llobregat, Spain, 08907
Sage Investigational Site
Madrid, Spain, 28040
Sweden
Sage Investigational Site
Gothenburg, Sweden, 413 45
United Kingdom
Sage Investigational Site
Manchester, United Kingdom, M6 8HD
Sage Investigational Site
Norfolk, United Kingdom, NR4 7UY
Sage Investigational Site
Norwich, United Kingdom, NR4 7UY
Sage Investigational Site
Staffordshire, United Kingdom, ST3 6QG
Sage Investigational Site
Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Sage Therapeutics
Investigators
Principal Investigator: Eric Rosenthal, MD Massachusetts General Hospital
Principal Investigator: Mark Wainwright, MD, PhD Ann & Robert H Lurie Children's Hospital of Chicago

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02477618     History of Changes
Other Study ID Numbers: 547-SSE-301
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases