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

October 1, 2025 updated by: Supernus Pharmaceuticals, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Sage Investigational Site
      • Salzburg, Austria, 5020
        • Sage Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H3V4
        • Sage Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Sage Investigational Site
      • Kingston, Ontario, Canada, K7L3C9
        • Sage Investigational Site
      • London, Ontario, Canada, N6A5A5
        • Sage Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Sage Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Sage Investigational Site
      • Montreal, Quebec, Canada, H3A 2B4
        • Sage Investigational Site
      • Montreal, Quebec, Canada, H3T1C5
        • Sage Investigational Site
      • Montreal, Quebec, Canada, H3T 1C5
        • Sage Investigational Site
  • Denmark
      • Copenhagen, Denmark, 2100
        • Sage Investigational Site
  • Estonia
      • Tallinn, Estonia, 10617
        • Sage Investigational Site
      • Tallinn, Estonia, 13419
        • Sage Investigational Site
      • Tartu, Estonia, 51014
        • Sage Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • Sage Investigational Site
      • Kuopio, Finland, 70210
        • Sage Investigational Site
  • France
      • Bron, France, 69677
        • Sage Investigational Site
      • Dijon, France, 21079
        • Sage Investigational Site
      • Lille, France, 59037
        • Sage Investigational Site
      • Limoges, France, 87042
        • Sage Investigational Site
      • Lyon, France, 69677
        • Sage Investigational Site
      • Paris, France, 75851
        • Sage Investigational Site
  • Germany
      • Hamburg, Germany, 22337
        • Sage Investigational Site
      • Marburg, Germany, 35043
        • Sage Investigational Site
      • Osnabrück, Germany, 49076
        • Sage Investigational Site
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Sage Investigational Site
      • Budapest, Hungary, 01134
        • Sage Investigational Site
      • Budapest, Hungary, 1134
        • Sage Investigational Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Sage Investigational Site
      • Holon, Israel, 58100
        • Sage Investigational Site
      • Holon, Israel
        • Sage Investigational Site
      • Jerusalem, Israel, 91120
        • Sage Investigational Site
      • Petah Tikva, Israel, 49100
        • Sage Investigational Site
      • Tel Litwinsky, Israel, 52621
        • Sage Investigational Site
      • Tzrifin, Israel, 70300
        • Sage Investigational Site
  • Italy
      • Bologna, Italy, 40139
        • Sage Investigational Site
      • Florence, Italy, 50139
        • Sage Investigational Site
      • Milan, Italy, 20132
        • Sage Investigational Site
      • Milan, Italy, 20133
        • Sage Investigational Site
      • Modena, Italy, 41100
        • Sage Investigational Site
      • Modena, Italy, 41126
        • Sage Investigational Site
      • Monza, Italy, 20900
        • Sage Investigational Site
      • Perugia, Italy, 06129
        • Sage Investigational Site
      • Reggio Calabria, Italy, 89124
        • Sage Investigational Site
      • Rome, Italy, 00165
        • Sage Investigational Site
      • Rome, Italy, 165
        • Sage Investigational Site
      • Verona, Italy, 37126
        • Sage Investigational Site
  • Netherlands
      • Enschede, Netherlands, 7512KZ
        • Sage Investigational Site
      • Heerlen, Netherlands, 6419PC
        • Sage Investigational Site
      • Maastricht, Netherlands, 6202AZ
        • Sage Investigational Site
      • Nijmegen, Netherlands, 6525GA
        • Sage Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Sage Investigational Site
      • Belgrade, Serbia, 11070
        • Sage Investigational Site
      • Niš, Serbia, 18000
        • Sage Investigational Site
      • Novi Sad, Serbia, 21000
        • Sage Investigational Site
  • Spain
      • Badalona, Spain, 8916
        • Sage Investigational Site
      • Barakaldo, Spain, 48903
        • Sage Investigational Site
      • Barcelona, Spain, 08035
        • Sage Investigational Site
      • Barcelona, Spain, 08036
        • Sage Investigational Site
      • Córdoba, Spain, 14004
        • Sage Investigational Site
      • Granada, Spain, 18016
        • Sage Investigational Site
      • L'Hospitalet de Llobregat, Spain, 08907
        • Sage Investigational Site
      • Madrid, Spain, 28040
        • Sage Investigational Site
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sage Investigational Site
  • United Kingdom
      • Manchester, United Kingdom, M6 8HD
        • Sage Investigational Site
      • Norfolk, United Kingdom, NR4 7UY
        • Sage Investigational Site
      • Norwich, United Kingdom, NR4 7UY
        • Sage Investigational Site
      • Staffordshire, United Kingdom, ST3 6QG
        • Sage Investigational Site
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Sage Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Sage Investigational Site
      • Mobile, Alabama, United States, 36667
        • Sage Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Sage Investigational Site
      • Phoenix, Arizona, United States, 85013
        • Sage Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 27702
        • Sage Investigational Site
    • California
      • Fresno, California, United States, 93721
        • Sage Investigational Site
      • Loma Linda, California, United States, 92354
        • Sage Investigational Site
      • Los Angeles, California, United States, 90027
        • Sage Investigational Site
      • Roseville, California, United States, 95661
        • Sage Investigational Site
      • Sacramento, California, United States, 95317
        • Sage Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Sage Investigational Site
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Sage Investigational Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Sage Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32611
        • Sage Investigational Site
      • Jacksonville, Florida, United States, 32209
        • Sage Investigational Site
      • Miami, Florida, United States, 33155
        • Sage Investigational Site
      • Orlando, Florida, United States, 32803
        • Sage Investigational Site
      • Sarasota, Florida, United States, 34239
        • Sage Investigational Site
      • Tampa, Florida, United States, 33613
        • Sage Investigational Site
      • Weston, Florida, United States, 33331
        • Sage Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Sage Investigational Site
      • Atlanta, Georgia, United States, 30303
        • Sage Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Sage Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Sage Investigational Site
      • Honolulu, Hawaii, United States, 96826
        • Sage Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Sage Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Sage Investigational Site
      • Chicago, Illinois, United States, 60612
        • Sage Investigational Site
      • Maywood, Illinois, United States, 60153
        • Sage Investigational Site
      • Peoria, Illinois, United States, 61637
        • Sage Investigational Site
      • Springfield, Illinois, United States, 62702
        • Sage Investigational Site
      • Urbana, Illinois, United States, 61801
        • Sage Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Sage Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Sage Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Sage Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Sage Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Sage Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • Sage Investigational Site
    • Maine
      • Portland, Maine, United States, 04102
        • Sage Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Sage Investigational Site
      • Baltimore, Maryland, United States, 21215
        • Sage Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Sage Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Sage Investigational Site
      • Boston, Massachusetts, United States, 02111
        • Sage Investigational Site
      • Boston, Massachusetts, United States, 02118
        • Sage Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Sage Investigational Site
      • Newton, Massachusetts, United States, 02462
        • Sage Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Sage Investigational Site
      • Detroit, Michigan, United States, 48201
        • Sage Investigational Site
      • Detroit, Michigan, United States, 48202
        • Sage Investigational Site
      • East Lansing, Michigan, United States, 48824
        • Sage Investigational Site
      • Grand Rapids, Michigan, United States, 49503
        • Sage Investigational Site
      • Royal Oak, Michigan, United States, 48073
        • Sage Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Sage Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Sage Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Sage Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Sage Investigational Site
      • St Louis, Missouri, United States, 63110
        • Sage Investigational Site
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • Sage Investigational Site
      • Morristown, New Jersey, United States, 08827
        • Sage Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Sage Investigational Site
      • Summit, New Jersey, United States, 07901
        • Sage Investigational Site
    • New York
      • Buffalo, New York, United States, 14203
        • Sage Investigational Site
      • New York, New York, United States, 10032
        • Sage Investigational Site
      • New York, New York, United States, 10016
        • Sage Investigational Site
      • New York, New York, United States, 10029
        • Sage Investigational Site
      • Port Jefferson, New York, United States, 11777
        • Sage Investigational Site
      • Rochester, New York, United States, 14642
        • Sage Investigational Site
      • Syracuse, New York, United States, 13210
        • Sage Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Sage Investigational Site
      • Winston-Salem, North Carolina, United States, 27157
        • Sage Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44308
        • Sage Investigational Site
      • Cincinnati, Ohio, United States, 45229
        • Sage Investigational Site
      • Cincinnati, Ohio, United States, 45267
        • Sage Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Sage Investigational Site
      • Columbus, Ohio, United States, 43210
        • Sage Investigational Site
      • Toledo, Ohio, United States, 43614
        • Sage Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Sage Investigational Site
      • Portland, Oregon, United States, 97225
        • Sage Investigational Site
      • Portland, Oregon, United States, 97239
        • Sage Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Sage Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Sage Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Sage Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Sage Investigational Site
      • Philadelphia, Pennsylvania, United States, 19141
        • Sage Investigational Site
      • Philadelphia, Pennsylvania, United States, 19147
        • Sage Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Sage Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Sage Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Sage Investigational Site
      • Nashville, Tennessee, United States, 37232
        • Sage Investigational Site
    • Texas
      • Austin, Texas, United States, 78723
        • Sage Investigational Site
      • Dallas, Texas, United States, 75251
        • Sage Investigational Site
      • San Antonio, Texas, United States, 78229
        • Sage Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Sage Investigational Site
      • Salt Lake City, Utah, United States, 84113
        • Sage Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Sage Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Sage Investigational Site
    • West Virginia
      • Huntington, West Virginia, United States, 25705
        • Sage Investigational Site
      • Morgantown, West Virginia, United States, 26506
        • Sage Investigational Site
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Sage Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Intravenous
Drug: Placebo
Placebo
Active Comparator: SAGE-547
Intravenous
Drug: SAGE-547

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 7 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Time Frame: Up to 21 days
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression 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.
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
Time Frame: Day 6
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression 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.
Day 6
Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Time Frame: Up to 21 days
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression 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.
Up to 21 days
Change in Clinical Global Impression Scale (CGI)
Time Frame: Up to 21 days
The CGI scale was used to integrate several sources of information into a single rating of a participant's condition. The CGI was rated on a 7-point scale, from a minimum of 0 to a maximum of 7, where 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline physically ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill participants. A negative change from baseline indicates improvement. A positive change from baseline indicates worsening. Here, study visits followed by "R" indicate the Open-label Treatment Period.
Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12
Time Frame: Up to 21 days
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12
Time Frame: Up to 21 days
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Up to 21 days
Number of Separate Episodes of Status Epilepticus Up to Visit 12
Time Frame: Up to 21 days
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Up to 21 days
Number of Participants With a New Diagnosis of Epilepsy After Visit 11
Time Frame: Up to 21 days
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Supernus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Rosenthal, MD, Massachusetts General Hospital
  • Principal Investigator: Mark Wainwright, MD, PhD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 547-SSE-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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