A Study With SAGE-547 for Super-Refractory Status Epilepticus

• Status: Completed
• Trial end date: 2017-08-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Brexanolone

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