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

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ClinicalTrials.gov Identifier: NCT02477618
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Super-Refractory Status Epilepticus Drug: SAGE-547 Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2015
Primary Completion Date : July 18, 2017
Study Completion Date : August 11, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: SAGE-547
Intravenous
Drug: SAGE-547
Placebo Comparator: Placebo
Intravenous
Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. Number of patients that are 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 following the end of the SAGE-547 or placebo infusion [ Time Frame: 7 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477618


  Show 173 Study Locations
Sponsors and Collaborators
Sage Therapeutics
Investigators
Principal Investigator: Eric Rosenthal, MD Massachusetts General Hospital
Principal Investigator: Mark Wainwright, MD, PhD Ann & Robert H Lurie Children's Hospital of Chicago
More Information

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02477618     History of Changes
Other Study ID Numbers: 547-SSE-301
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases