NO_LONGER_AVAILABLENot Applicable

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

Plain-language 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

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.

Trial details

NCT IDNCT02433314

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Super-Refractory Status Epilepticus trials