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New drug shows promise for stopping Life-Threatening seizures

NCT ID NCT02477618

Disease control Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called SAGE-547 in 132 people with super-refractory status epilepticus, a dangerous condition where seizures don't stop with standard treatments. The drug was given as a continuous IV infusion to see if it could help patients come off strong sedatives and stay seizure-free. The trial was double-blind and placebo-controlled, meaning neither patients nor doctors knew who got the real drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAGE-547 injection (a drug given intravenously to stop prolonged seizures)
What this could lead to
If it works, this could provide a new treatment to help people with life-threatening, drug-resistant seizures recover faster and reduce the need for heavy sedation.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely confirmed. The condition is rare and severe, so benefits may not apply to all patients, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

132 people

The number who actually took part.

Start date

Jun 2015

Finished

Aug 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Super-refractory status epilepticus

Contacts and locations

Locations

  • Sage Investigational Site

    Birmingham, Alabama, 35233, United States

  • Sage Investigational Site

    Mobile, Alabama, 36667, United States

  • Sage Investigational Site

    Phoenix, Arizona, 85006, United States

  • Sage Investigational Site

    Phoenix, Arizona, 85013, United States

  • Sage Investigational Site

    Little Rock, Arkansas, 27702, United States

  • Sage Investigational Site

    Fresno, California, 93721, United States

  • Sage Investigational Site

    Loma Linda, California, 92354, United States

  • Sage Investigational Site

    Los Angeles, California, 90027, United States

  • Sage Investigational Site

    Roseville, California, 95661, United States

  • Sage Investigational Site

    Sacramento, California, 95317, United States

  • Sage Investigational Site

    New Haven, Connecticut, 06510, United States

  • Sage Investigational Site

    Wilmington, Delaware, 19803, United States

  • Sage Investigational Site

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

  • Sage Investigational Site

    Gainesville, Florida, 32611, United States

  • Sage Investigational Site

    Jacksonville, Florida, 32209, United States

  • Sage Investigational Site

    Miami, Florida, 33155, United States

  • Sage Investigational Site

    Orlando, Florida, 32803, United States

  • Sage Investigational Site

    Sarasota, Florida, 34239, United States

  • Sage Investigational Site

    Tampa, Florida, 33613, United States

  • Sage Investigational Site

    Weston, Florida, 33331, United States

  • Sage Investigational Site

    Atlanta, Georgia, 30303, United States

  • Sage Investigational Site

    Atlanta, Georgia, 30322, United States

  • Sage Investigational Site

    Atlanta, Georgia, 30342, United States

  • Sage Investigational Site

    Honolulu, Hawaii, 96813, United States

  • Sage Investigational Site

    Honolulu, Hawaii, 96826, United States

  • Sage Investigational Site

    Boise, Idaho, 83706, United States

  • Sage Investigational Site

    Chicago, Illinois, 60611, United States

  • Sage Investigational Site

    Chicago, Illinois, 60612, United States

  • Sage Investigational Site

    Maywood, Illinois, 60153, United States

  • Sage Investigational Site

    Peoria, Illinois, 61637, United States

  • Sage Investigational Site

    Springfield, Illinois, 62702, United States

  • Sage Investigational Site

    Urbana, Illinois, 61801, United States

  • Sage Investigational Site

    Iowa City, Iowa, 52242, United States

  • Sage Investigational Site

    Wichita, Kansas, 67214, United States

  • Sage Investigational Site

    Lexington, Kentucky, 40536, United States

  • Sage Investigational Site

    Louisville, Kentucky, 40202, United States

  • Sage Investigational Site

    Baton Rouge, Louisiana, 70808, United States

  • Sage Investigational Site

    New Orleans, Louisiana, 70115, United States

  • Sage Investigational Site

    Portland, Maine, 04102, United States

  • Sage Investigational Site

    Baltimore, Maryland, 21201, United States

  • Sage Investigational Site

    Baltimore, Maryland, 21215, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02111, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02114, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02115, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02118, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02215, United States

  • Sage Investigational Site

    Newton, Massachusetts, 02462, United States

  • Sage Investigational Site

    Ann Arbor, Michigan, 48109, United States

  • Sage Investigational Site

    Detroit, Michigan, 48201, United States

  • Sage Investigational Site

    Detroit, Michigan, 48202, United States

  • Sage Investigational Site

    East Lansing, Michigan, 48824, United States

  • Sage Investigational Site

    Grand Rapids, Michigan, 49503, United States

  • Sage Investigational Site

    Royal Oak, Michigan, 48073, United States

  • Sage Investigational Site

    Minneapolis, Minnesota, 55414, United States

  • Sage Investigational Site

    Rochester, Minnesota, 55905, United States

  • Sage Investigational Site

    Jackson, Mississippi, 39216, United States

  • Sage Investigational Site

    Kansas City, Missouri, 64108, United States

  • Sage Investigational Site

    St Louis, Missouri, 63110, United States

  • Sage Investigational Site

    Edison, New Jersey, 08818, United States

  • Sage Investigational Site

    Morristown, New Jersey, 08827, United States

  • Sage Investigational Site

    New Brunswick, New Jersey, 08901, United States

  • Sage Investigational Site

    Summit, New Jersey, 07901, United States

  • Sage Investigational Site

    Buffalo, New York, 14203, United States

  • Sage Investigational Site

    New York, New York, 10016, United States

  • Sage Investigational Site

    New York, New York, 10029, United States

  • Sage Investigational Site

    New York, New York, 10032, United States

  • Sage Investigational Site

    Port Jefferson, New York, 11777, United States

  • Sage Investigational Site

    Rochester, New York, 14642, United States

  • Sage Investigational Site

    Syracuse, New York, 13210, United States

  • Sage Investigational Site

    Durham, North Carolina, 27710, United States

  • Sage Investigational Site

    Winston-Salem, North Carolina, 27157, United States

  • Sage Investigational Site

    Akron, Ohio, 44308, United States

  • Sage Investigational Site

    Cincinnati, Ohio, 45229, United States

  • Sage Investigational Site

    Cincinnati, Ohio, 45267, United States

  • Sage Investigational Site

    Cleveland, Ohio, 44195, United States

  • Sage Investigational Site

    Columbus, Ohio, 43210, United States

  • Sage Investigational Site

    Toledo, Ohio, 43614, United States

  • Sage Investigational Site

    Portland, Oregon, 97213, United States

  • Sage Investigational Site

    Portland, Oregon, 97225, United States

  • Sage Investigational Site

    Portland, Oregon, 97239, United States

  • Sage Investigational Site

    Hershey, Pennsylvania, 17033, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19107, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19140, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19141, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19147, United States

  • Sage Investigational Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Sage Investigational Site

    Charleston, South Carolina, 29425, United States

  • Sage Investigational Site

    Memphis, Tennessee, 38105, United States

  • Sage Investigational Site

    Nashville, Tennessee, 37232, United States

  • Sage Investigational Site

    Austin, Texas, 78723, United States

  • Sage Investigational Site

    Dallas, Texas, 75251, United States

  • Sage Investigational Site

    Salt Lake City, Utah, 84108, United States

  • Sage Investigational Site

    Salt Lake City, Utah, 84113, United States

  • Sage Investigational Site

    Burlington, Vermont, 05401, United States

  • Sage Investigational Site

    Seattle, Washington, 98105, United States

  • Sage Investigational Site

    Huntington, West Virginia, 25705, United States

  • Sage Investigational Site

    Morgantown, West Virginia, 26506, United States

  • Sage Investigational Site

    Wauwatosa, Wisconsin, 53226, United States

  • Sage Investigational Site

    Innsbruck, 6020, Austria

  • Sage Investigational Site

    Salzburg, 5020, Austria

  • Sage Investigational Site

    Vancouver, British Columbia, V6H3V4, Canada

  • Sage Investigational Site

    Hamilton, Ontario, L8L 2X2, Canada

  • Sage Investigational Site

    Kingston, Ontario, K7L3C9, Canada

  • Sage Investigational Site

    London, Ontario, N6A5A5, Canada

  • Sage Investigational Site

    Montreal, Quebec, H1T 2M4, Canada

  • Sage Investigational Site

    Montreal, Quebec, H2L 4M1, Canada

  • Sage Investigational Site

    Montreal, Quebec, H3A 2B4, Canada

  • Sage Investigational Site

    Montreal, Quebec, H3T 1C5, Canada

  • Sage Investigational Site

    Montreal, Quebec, H3T1C5, Canada

  • Sage Investigational Site

    Copenhagen, 2100, Denmark

  • Sage Investigational Site

    Tallinn, 10617, Estonia

  • Sage Investigational Site

    Tallinn, 13419, Estonia

  • Sage Investigational Site

    Tartu, 51014, Estonia

  • Sage Investigational Site

    Helsinki, 00029, Finland

  • Sage Investigational Site

    Kuopio, 70210, Finland

  • Sage Investigational Site

    Bron, 69677, France

  • Sage Investigational Site

    Dijon, 21079, France

  • Sage Investigational Site

    Lille, 59037, France

  • Sage Investigational Site

    Limoges, 87042, France

  • Sage Investigational Site

    Lyon, 69677, France

  • Sage Investigational Site

    Paris, 75851, France

  • Sage Investigational Site

    Hamburg, 22337, Germany

  • Sage Investigational Site

    Marburg, 35043, Germany

  • Sage Investigational Site

    Osnabrück, 49076, Germany

  • Sage Investigational Site

    Balassagyarmat, 2660, Hungary

  • Sage Investigational Site

    Budapest, 01134, Hungary

  • Sage Investigational Site

    Budapest, 1134, Hungary

  • Sage Investigational Site

    Ashkelon, 7830604, Israel

  • Sage Investigational Site

    Holon, 58100, Israel

  • Sage Investigational Site

    Holon, Israel

  • Sage Investigational Site

    Jerusalem, 91120, Israel

  • Sage Investigational Site

    Petah Tikva, 49100, Israel

  • Sage Investigational Site

    Tel Litwinsky, 52621, Israel

  • Sage Investigational Site

    Tzrifin, 70300, Israel

  • Sage Investigational Site

    Bologna, 40139, Italy

  • Sage Investigational Site

    Florence, 50139, Italy

  • Sage Investigational Site

    Milan, 20132, Italy

  • Sage Investigational Site

    Milan, 20132, Italy

  • Sage Investigational Site

    Milan, 20133, Italy

  • Sage Investigational Site

    Modena, 41100, Italy

  • Sage Investigational Site

    Modena, 41126, Italy

  • Sage Investigational Site

    Monza, 20900, Italy

  • Sage Investigational Site

    Perugia, 06129, Italy

  • Sage Investigational Site

    Reggio Calabria, 89124, Italy

  • Sage Investigational Site

    Rome, 00165, Italy

  • Sage Investigational Site

    Rome, 165, Italy

  • Sage Investigational Site

    Verona, 37126, Italy

  • Sage Investigational Site

    Enschede, 7512KZ, Netherlands

  • Sage Investigational Site

    Heerlen, 6419PC, Netherlands

  • Sage Investigational Site

    Maastricht, 6202AZ, Netherlands

  • Sage Investigational Site

    Nijmegen, 6525GA, Netherlands

  • Sage Investigational Site

    Belgrade, 11000, Serbia

  • Sage Investigational Site

    Belgrade, 11070, Serbia

  • Sage Investigational Site

    Niš, 18000, Serbia

  • Sage Investigational Site

    Novi Sad, 21000, Serbia

  • Sage Investigational Site

    Badalona, 8916, Spain

  • Sage Investigational Site

    Barakaldo, 48903, Spain

  • Sage Investigational Site

    Barcelona, 08035, Spain

  • Sage Investigational Site

    Barcelona, 08036, Spain

  • Sage Investigational Site

    Córdoba, 14004, Spain

  • Sage Investigational Site

    Granada, 18016, Spain

  • Sage Investigational Site

    L'Hospitalet de Llobregat, 08907, Spain

  • Sage Investigational Site

    Madrid, 28040, Spain

  • Sage Investigational Site

    Gothenburg, 413 45, Sweden

  • Sage Investigational Site

    Manchester, M6 8HD, United Kingdom

  • Sage Investigational Site

    Norfolk, NR4 7UY, United Kingdom

  • Sage Investigational Site

    Norwich, NR4 7UY, United Kingdom

  • Sage Investigational Site

    Staffordshire, ST3 6QG, United Kingdom

  • Sage Investigational Site

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

  • Sage investigational Site

    San Antonio, Texas, 78229, United States

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