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
About this trial
This is an expanded access trial for Super-Refractory Status Epilepticus
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
Learn more about this trial
An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus
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