A Study With SAGE-547 for Super-Refractory Status Epilepticus
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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).
Number of patients that are 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 following the end of the SAGE-547 or placebo infusion [ Time Frame: 7 days ]
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Ages Eligible for Study:
2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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