A Study With SAGE-547 for Super-Refractory Status Epilepticus
Condition: Super-Refractory Status Epilepticus
MeSH terms: Status Epilepticus
Intervention: SAGE-547; Placebo
Intervention description: Placebo
Intervention MeSH terms: Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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:

               1. 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®);

               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 (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