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An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus

Primary Purpose

Super-Refractory Status Epilepticus

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
SAGE-547
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Super-Refractory Status Epilepticus

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Subjects six (6) months 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 AED treatment), according to the institution's 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 AEDs), according to the institution's 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 agents 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 at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents 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 18 years) with an encephalopathy due to an underlying progressive neurological disorder
  • Subjects who have any of the following:

    1. a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned;
    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 or life-expectancy of 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

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 29, 2015
    Last Updated
    November 10, 2017
    Sponsor
    Sage Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02433314
    Brief Title
    An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus
    Official Title
    An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects

    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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SAGE-547

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Eligibility Criteria
    Inclusion Criteria: Subjects six (6) months 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 AED treatment), according to the institution's 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 AEDs), according to the institution's 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 agents 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 at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents 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 18 years) with an encephalopathy due to an underlying progressive neurological disorder Subjects who have any of the following: a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned; 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 or life-expectancy of 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
    Henrikas Vaitkevicius, MD
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.sagerx.com
    Description
    Related Info

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    An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus

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