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

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.