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

NCT02477618 | Completed Phase 3 Results DMC

• 1 other identifier: 547-SSE-301
• Study Type: interventional
• Target: 132
• Locations: 14 countries
• Sites: 159

Brief 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).

Conditions

Super-Refractory Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion

  Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression electroencephalogram (EEG) pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was 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 after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.

  7 days

Secondary Outcomes (8)

• Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression

  Up to 21 days

• Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion

  Day 6

• Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression

  Up to 21 days

• Change in Clinical Global Impression Scale (CGI)

  Up to 21 days

• Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12

  Up to 21 days

Study Arms (2)

SAGE-547

ACTIVE COMPARATOR

Intravenous

Drug: SAGE-547

Placebo

PLACEBO COMPARATOR

Intravenous

Drug: Placebo

Interventions

SAGE-547 DRUG

SAGE-547

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (171)

Sage Investigational Site

Birmingham, Alabama, 35233, United States

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Mobile, Alabama, 36667, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85013, United States

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Little Rock, Arkansas, 27702, United States

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Fresno, California, 93721, United States

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Loma Linda, California, 92354, United States

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Los Angeles, California, 90027, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95317, United States

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New Haven, Connecticut, 06510, United States

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Wilmington, Delaware, 19803, United States

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Washington D.C., District of Columbia, 20010, United States

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Gainesville, Florida, 32611, United States

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Jacksonville, Florida, 32209, United States

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Miami, Florida, 33155, United States

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Orlando, Florida, 32803, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33613, United States

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Weston, Florida, 33331, United States

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Atlanta, Georgia, 30303, United States

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Atlanta, Georgia, 30322, United States

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Atlanta, Georgia, 30342, United States

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Honolulu, Hawaii, 96813, United States

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Honolulu, Hawaii, 96826, United States

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Boise, Idaho, 83706, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Maywood, Illinois, 60153, United States

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Peoria, Illinois, 61637, United States

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Springfield, Illinois, 62702, United States

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Urbana, Illinois, 61801, United States

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Iowa City, Iowa, 52242, United States

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Wichita, Kansas, 67214, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Baton Rouge, Louisiana, 70808, United States

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New Orleans, Louisiana, 70115, United States

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Portland, Maine, 04102, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21215, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02118, United States

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Boston, Massachusetts, 02215, United States

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Newton, Massachusetts, 02462, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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East Lansing, Michigan, 48824, United States

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Grand Rapids, Michigan, 49503, United States

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Royal Oak, Michigan, 48073, United States

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Minneapolis, Minnesota, 55414, United States

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Rochester, Minnesota, 55905, United States

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Jackson, Mississippi, 39216, United States

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Kansas City, Missouri, 64108, United States

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St Louis, Missouri, 63110, United States

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Edison, New Jersey, 08818, United States

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Morristown, New Jersey, 08827, United States

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New Brunswick, New Jersey, 08901, United States

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Summit, New Jersey, 07901, United States

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Buffalo, New York, 14203, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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New York, New York, 10032, United States

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Port Jefferson, New York, 11777, United States

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Rochester, New York, 14642, United States

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Syracuse, New York, 13210, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Akron, Ohio, 44308, United States

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Cincinnati, Ohio, 45229, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Toledo, Ohio, 43614, United States

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Portland, Oregon, 97213, United States

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Portland, Oregon, 97225, United States

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Portland, Oregon, 97239, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19140, United States

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Philadelphia, Pennsylvania, 19141, United States

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Philadelphia, Pennsylvania, 19147, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Charleston, South Carolina, 29425, United States

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Memphis, Tennessee, 38105, United States

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Nashville, Tennessee, 37232, United States

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Austin, Texas, 78723, United States

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Dallas, Texas, 75251, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84108, United States

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Salt Lake City, Utah, 84113, United States

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Burlington, Vermont, 05401, United States

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Seattle, Washington, 98105, United States

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Huntington, West Virginia, 25705, United States

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Morgantown, West Virginia, 26506, United States

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Wauwatosa, Wisconsin, 53226, United States

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Innsbruck, 6020, Austria

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Salzburg, 5020, Austria

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Vancouver, British Columbia, V6H3V4, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Kingston, Ontario, K7L3C9, Canada

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London, Ontario, N6A5A5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Montreal, Quebec, H3T 1C5, Canada

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Montreal, Quebec, H3T1C5, Canada

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Copenhagen, 2100, Denmark

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Tallinn, 10617, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Helsinki, 00029, Finland

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Kuopio, 70210, Finland

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Bron, 69677, France

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Dijon, 21079, France

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Lille, 59037, France

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Limoges, 87042, France

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Lyon, 69677, France

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Paris, 75851, France

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Hamburg, 22337, Germany

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Marburg, 35043, Germany

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Osnabrück, 49076, Germany

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Balassagyarmat, 2660, Hungary

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Budapest, 01134, Hungary

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Budapest, 1134, Hungary

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Ashkelon, 7830604, Israel

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Holon, 58100, Israel

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Holon, Israel

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Jerusalem, 91120, Israel

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Petah Tikva, 49100, Israel

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Tel Litwinsky, 52621, Israel

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Tzrifin, 70300, Israel

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Bologna, 40139, Italy

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Florence, 50139, Italy

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Milan, 20132, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Modena, 41100, Italy

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Modena, 41126, Italy

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Monza, 20900, Italy

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Perugia, 06129, Italy

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Reggio Calabria, 89124, Italy

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Rome, 00165, Italy

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Rome, 165, Italy

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Verona, 37126, Italy

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Enschede, 7512KZ, Netherlands

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Heerlen, 6419PC, Netherlands

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Maastricht, 6202AZ, Netherlands

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Nijmegen, 6525GA, Netherlands

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Belgrade, 11000, Serbia

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Belgrade, 11070, Serbia

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Niš, 18000, Serbia

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Novi Sad, 21000, Serbia

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Badalona, 8916, Spain

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Barakaldo, 48903, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Granada, 18016, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Madrid, 28040, Spain

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Gothenburg, 413 45, Sweden

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Manchester, M6 8HD, United Kingdom

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Norfolk, NR4 7UY, United Kingdom

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Norwich, NR4 7UY, United Kingdom

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Staffordshire, ST3 6QG, United Kingdom

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Stoke-on-Trent, ST4 6QG, United Kingdom

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Related Links

• Sage Therapeutics

MeSH Terms

Interventions

brexanolone

Results Point of Contact

• Title: Helen Colquhoun, MD - Vice President, Medical Science
• Organization: Sage Therapeutics

Helen@sagerx.com

(617) 229-5234

Study Officials

• Eric Rosenthal, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Mark Wainwright, MD, PhD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: July 18, 2017
• Study Completion: August 11, 2017
• Last Updated: October 14, 2025
• Results First Posted: May 2, 2019

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4); US (100); GB (5); SE (1); FI (2); IT (13); ES (3); DE (3); HU (3); FR (6); CA (9); IL (7); AU (2); DK (1)