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A Study With SAGE-547 for Sup...

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

Last Updated: 2025-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-08-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Super-Refractory Status Epilepticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAGE-547

Intravenous

Group Type ACTIVE_COMPARATOR

SAGE-547

Intervention Type DRUG

Placebo

Intravenous

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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SAGE-547

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Mark Wainwright, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Sage Investigational Site

Birmingham, Alabama, United States

Site Status

Sage Investigational Site

Mobile, Alabama, United States

Site Status

Sage Investigational Site

Phoenix, Arizona, United States

Site Status

Sage Investigational Site

Phoenix, Arizona, United States

Site Status

Sage Investigational Site

Little Rock, Arkansas, United States

Site Status

Sage Investigational Site

Fresno, California, United States

Site Status

Sage Investigational Site

Loma Linda, California, United States

Site Status

Sage Investigational Site

Los Angeles, California, United States

Site Status

Sage Investigational Site

Roseville, California, United States

Site Status

Sage Investigational Site

Sacramento, California, United States

Site Status

Sage Investigational Site

New Haven, Connecticut, United States

Site Status

Sage Investigational Site

Wilmington, Delaware, United States

Site Status

Sage Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Sage Investigational Site

Gainesville, Florida, United States

Site Status

Sage Investigational Site

Jacksonville, Florida, United States

Site Status

Sage Investigational Site

Miami, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

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Sage Investigational Site

Sarasota, Florida, United States

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Sage Investigational Site

Tampa, Florida, United States

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Sage Investigational Site

Weston, Florida, United States

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Sage Investigational Site

Atlanta, Georgia, United States

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Sage Investigational Site

Atlanta, Georgia, United States

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Sage Investigational Site

Atlanta, Georgia, United States

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Sage Investigational Site

Honolulu, Hawaii, United States

Site Status

Sage Investigational Site

Honolulu, Hawaii, United States

Site Status

Sage Investigational Site

Boise, Idaho, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Maywood, Illinois, United States

Site Status

Sage Investigational Site

Peoria, Illinois, United States

Site Status

Sage Investigational Site

Springfield, Illinois, United States

Site Status

Sage Investigational Site

Urbana, Illinois, United States

Site Status

Sage Investigational Site

Iowa City, Iowa, United States

Site Status

Sage Investigational Site

Wichita, Kansas, United States

Site Status

Sage Investigational Site

Lexington, Kentucky, United States

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Sage Investigational Site

Louisville, Kentucky, United States

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Sage Investigational Site

Baton Rouge, Louisiana, United States

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Sage Investigational Site

New Orleans, Louisiana, United States

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Sage Investigational Site

Portland, Maine, United States

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Sage Investigational Site

Baltimore, Maryland, United States

Site Status