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

Supernus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Super-Refractory Status Epilepticus

Treatments: Drug: SAGE-547; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02477618

547-SSE-301

Details and patient eligibility

About

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).

Enrollment: 132 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups, including a placebo group

SAGE-547

Active Comparator group

Description:

Intravenous

Treatment:

Drug: SAGE-547

Placebo

Placebo Comparator group

Description:

Intravenous

Treatment:

Drug: Placebo