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Trial record 1 of 1 for:    nct02477618
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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):

June 2, 2015
June 23, 2015
September 12, 2017
June 2015
July 18, 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02477618 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study With SAGE-547 for Super-Refractory Status Epilepticus
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Super-Refractory Status Epilepticus
  • Drug: SAGE-547
  • Drug: Placebo
    Placebo
  • Active Comparator: SAGE-547
    Intravenous
    Intervention: Drug: SAGE-547
  • Placebo Comparator: Placebo
    Intravenous
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
August 11, 2017
July 18, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   Denmark,   Estonia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Serbia,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT02477618
547-SSE-301
Yes
Not Provided
Not Provided
Sage Therapeutics
Sage Therapeutics
Not Provided
Principal Investigator: Eric Rosenthal, MD Massachusetts General Hospital
Principal Investigator: Mark Wainwright, MD, PhD Ann & Robert H Lurie Children's Hospital of Chicago
Sage Therapeutics
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP