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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.
 
ClinicalTrials.gov Identifier: NCT02052739
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : April 26, 2017
Sponsor:
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.

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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
SAGE-547
Drug: SAGE-547
Intravenous




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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02052739


Locations
Show Show 18 study locations
Sponsors and Collaborators
Sage Therapeutics
Investigators
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Study Chair: Stephen J Kanes, M.D., Ph.D. Sage Therapeutics

Additional Information:
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02052739    
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-547
SAGE
Sage Therapeutics
Additional relevant MeSH terms:
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Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs