Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
NCT ID: NCT02052739
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2014-03-21
2015-05-03
Brief Summary
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Detailed Description
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On Day 1 of treatment SRSE participants under seizure suppression or burst-suppression with a continuous intravenous (IV) anti-epileptic drug (AED) (third-line agent) were 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) was 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 was to be tapered and discontinued over 24 hours.
The participants would have routine continuous electroencephalogram (EEG) monitoring during the screening period, and continuing until 48 hours after SAGE-547 treatment had completed. Participants would then have follow-up examinations weekly for the next 3 weeks (Days 8, 15, 22, and 29), during which safety and functional assessments would be obtained. Apart from treatment with SAGE-547, all participants would receive the standard of care for adults in SRSE along with ongoing treatment for all underlying medical conditions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SAGE-547 Standard Dose
Participants received SAGE-547 IV loading infusion of 286.6 micrograms per kilogram per hour (μg/kg/hr) for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for next 95 hours from Days 1 to 4 (i.e. up to Hour 96) followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5.
SAGE-547
Solution for injection for IV infusion
SAGE-547 High Dose
Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of SAGE-547 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of SAGE-547 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5.
SAGE-547
Solution for injection for IV infusion
Interventions
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SAGE-547
Solution for injection for IV infusion
Eligibility Criteria
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Inclusion Criteria
* Participants 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
* Participants with clinically significant electrocardiogram abnormalities.
* Participants with a significant medical or surgical condition that may compromise vital organ systems, or other conditions that would place the participants 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.
* Participants who are receiving a continuous IV AED (third-line agent) for seizure suppression or burst-suppression that would require greater than 24 hours to wean.
2 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Lasser, MD, MBA
Role: STUDY_CHAIR
Sage Therapeutics
Locations
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Sage Investigational Site
Birmingham, Alabama, United States
Sage Investigational Site
Sarasota, Florida, United States
Sage Investigational Site
Chicago, Illinois, United States
Sage Investigational Site
Wichita, Kansas, United States
Sage Investigational Site
New Orleans, Louisiana, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Ann Arbor, Michigan, United States
Sage Investigational Site
Detroit, Michigan, United States
Sage Investigational Site
New York, New York, United States
Sage Investigational Site
Rochester, New York, United States
Sage Investigational Site
Durham, North Carolina, United States
Sage Investigational Site
Winston-Salem, North Carolina, United States
Sage Investigational Site
Philadelphia, Pennsylvania, United States
Sage Investigational Site
Nashville, Tennessee, United States
Sage Investigational Site
Dallas, Texas, United States
Sage Investigational Site
Temple, Texas, United States
Countries
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References
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Rosenthal ES, Claassen J, Wainwright MS, Husain AM, Vaitkevicius H, Raines S, Hoffmann E, Colquhoun H, Doherty JJ, Kanes SJ. Brexanolone as adjunctive therapy in super-refractory status epilepticus. Ann Neurol. 2017 Sep;82(3):342-352. doi: 10.1002/ana.25008. Epub 2017 Sep 11.
Related Links
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Sage Therapeutics
Other Identifiers
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547-SSE-201
Identifier Type: -
Identifier Source: org_study_id
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