An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus

NCT02433314 | Unknown

• 1 other identifier: 547-SSE-302
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects

Conditions

Super-Refractory Status Epilepticus

Interventions

SAGE-547 DRUG

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects six (6) months 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 the institution's 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 AEDs), according to the institution's 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 agents 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 at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents but not in an EEG burst or seizure suppression pattern.

You may not qualify if:

• Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
• Children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder
• Subjects who have any of the following:
• a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned;
• severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
• fulminant hepatic failure;
• no reasonable expectation of recovery or life-expectancy of 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

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Related Links

• Related Info

MeSH Terms

Interventions

brexanolone

Study Officials

• Henrikas Vaitkevicius, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 4, 2015
• Last Updated: September 15, 2025

Record last verified: 2025-09