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Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus (SRSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02052739
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in subjects in super-refractory status epilepticus (SRSE).

Condition or disease Intervention/treatment Phase
Super-refractory Status Epilepticus Drug: SAGE-547 Phase 1 Phase 2

Detailed Description:

This is an open-label study consisting of a Screening period (1 day), 4-day treatment period (96 hours) followed by a 1-day dose taper period (24 hours), a 2-day acute follow-up period, and a 3 week extended follow-up period.

On Day 1 of treatment SRSE subjects under seizure suppression or burst-suppression with a continuous IV AED (third-line agent) will be given a 1-hour IV loading infusion of SAGE-547 followed by a maintenance infusion. After 48 hours of SAGE-547 treatment, the continuous IV AED (third-line agent) will be weaned while continuing SAGE-547 at the maintenance infusion for the remainder of the treatment period. After 96 hours (4 days) of therapy with SAGE-547, the dose will be tapered and discontinued over 24 hours.

The subjects will have routine continuous EEG monitoring during the Screening period, and continuing until 48 hours after SAGE-547 treatment has completed. Subjects will then have follow-up examinations weekly for the next 3 weeks (Days 8, 15, 22, and 29), during which safety and functional assessments will be obtained. Apart from treatment with SAGE-547, all subjects will receive the standard of care for adults in SRSE along with ongoing treatment for all underlying medical conditions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: active drug
Drug: SAGE-547

Primary Outcome Measures :
  1. Safety and tolerability in subjects in super-refractory status epilepticus (SRSE) [ Time Frame: 29 Days ]
    Safety will be evaluated via clinical laboratory measures, vitals, EEG and ECG throughout the 29 day study period

Secondary Outcome Measures :
  1. Efficacy of SAGE-547 on super-refractory status epilepticus as indicated by the need to re-institute a continuous IV AED (third-line agent), for refractory seizure control as well as the duration of the observed response [ Time Frame: 96 hours ]
  2. Pharmacokinetics (PK) of SAGE-547 exposure [ Time Frame: 7 Days ]
    Plasma PK parameters will be calculated where appropriate (eg, Cmax, Cmin, Tmax, AUClast, AUC∞, CLs). It will be collected prior to, during, and after completion of SAGE-547 dosing.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subjects 2 years of age and older.
  • Subjects with an EEG-confirmed SRSE diagnosis under concomitant therapy with a continuous IV AED (third-line agent) for ≥ 24 hours. For this study, SRSE is defined by the following criteria and in accordance with those used at major epilepsy treatment centers:

    • Failure 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
    • Failure 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
    • Presence of one or more breakthrough seizures > 6 hours after initiation of the continuous IV AED/third-line agent (e.g., pentobarbital, midazolam, propofol)

Exclusion Criteria:

  • Subjects with SRSE due to anoxic/hypoxic encephalopathy, children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder.
  • Subjects with clinically significant electrocardiogram (ECG) abnormalities.
  • Subjects with a significant medical or surgical condition that may compromise vital organ systems, or other conditions that would place the subject at increased risk such as dialysis or acute respiratory distress syndrome, severe cardiogenic or vasodilatory shock requiring 2 or more pressors, fulminant hepatic failure, etc.
  • Subjects who are receiving a continuous IV AED (third-line agent) for seizure suppression or burst-suppression that will require greater than 24 hours to wean.

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 identifier (NCT number): NCT02052739

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
Intercoastal Medical Group
Sarasota, Florida, United States, 34239
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
Via Christi Epilepsy Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48322
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Neurological Clinic of Texas, PA
Dallas, Texas, United States, 75251
Baylor Scott & White
Temple, Texas, United States, 76504
Sponsors and Collaborators
Sage Therapeutics
Study Chair: Stephen J Kanes, M.D., Ph.D. Sage Therapeutics

Additional Information:
Responsible Party: Sage Therapeutics Identifier: NCT02052739     History of Changes
Other Study ID Numbers: 547-SSE-201
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Sage Therapeutics:
Status Epilepticus
Refractory status epilepticus
Super-refractory status epilepticus
Sage Therapeutics

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