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

NCT02477618 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-10-14

Study results available
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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).

Conditions

  • Super-Refractory Status Epilepticus

Interventions

DRUG

SAGE-547

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Rosenthal, MD · Massachusetts General Hospital

  • Mark Wainwright, MD, PhD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-07-18
Completion
2017-08-11

Countries

  • United States
  • Austria
  • Canada
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Serbia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477618 on ClinicalTrials.gov