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

Primary Purpose

Super-Refractory Status Epilepticus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SAGE-547
Placebo
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Super-Refractory Status Epilepticus

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sage Investigational Site
  • Sage Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SAGE-547

Placebo

Arm Description

Intravenous

Intravenous

Outcomes

Primary Outcome Measures

Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression electroencephalogram (EEG) pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was 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 after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.

Secondary Outcome Measures

Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was 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 after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
Change in Clinical Global Impression Scale (CGI)
The CGI scale was used to integrate several sources of information into a single rating of a participant's condition. The CGI was rated on a 7-point scale, from a minimum of 0 to a maximum of 7, where 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline physically ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill participants. A negative change from baseline indicates improvement. A positive change from baseline indicates worsening. Here, study visits followed by "R" indicate the Open-label Treatment Period.
Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Number of Separate Episodes of Status Epilepticus Up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Number of Participants With a New Diagnosis of Epilepsy After Visit 11
Here, study visits followed by "R" indicate the Open-label Treatment Period.

Full Information

First Posted
June 2, 2015
Last Updated
January 20, 2022
Sponsor
Sage Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02477618
Brief Title
A Study With SAGE-547 for Super-Refractory Status Epilepticus
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 Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
August 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Super-Refractory Status Epilepticus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAGE-547
Arm Type
Active Comparator
Arm Description
Intravenous
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
SAGE-547
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion
Description
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression electroencephalogram (EEG) pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was 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 after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Description
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was 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 after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
Time Frame
Up to 21 days
Title
Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion
Description
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
Time Frame
Day 6
Title
Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Description
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
Time Frame
Up to 21 days
Title
Change in Clinical Global Impression Scale (CGI)
Description
The CGI scale was used to integrate several sources of information into a single rating of a participant's condition. The CGI was rated on a 7-point scale, from a minimum of 0 to a maximum of 7, where 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline physically ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill participants. A negative change from baseline indicates improvement. A positive change from baseline indicates worsening. Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time Frame
Up to 21 days
Title
Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12
Description
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time Frame
Up to 21 days
Title
Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12
Description
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time Frame
Up to 21 days
Title
Number of Separate Episodes of Status Epilepticus Up to Visit 12
Description
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time Frame
Up to 21 days
Title
Number of Participants With a New Diagnosis of Epilepsy After Visit 11
Description
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time Frame
Up to 21 days

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Links:
URL
http://www.sagerx.com
Description
Sage Therapeutics

Learn more about this trial

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

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