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

Launched by SAGE THERAPEUTICS · Apr 29, 2015

Keywords

ClinConnect Summary

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Gender

ALL

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:
• • 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