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

NCT ID: NCT02433314

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:

1. a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned;

2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;

3. fulminant hepatic failure;

4. 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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrikas Vaitkevicius, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Related Links

http://www.sagerx.com

Related Info

Other Identifiers

547-SSE-302

Identifier Type: -

Identifier Source: org_study_id