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

Super-Refractory Status Epilepticus Clinical Trial

Official title:

An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02433314
• Other study ID #: 547-SSE-302
• Status: No longer available
• Phase: N/A
• First received: April 29, 2015
• Last updated: November 10, 2017

Study information

• Verified date: November 2017
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Status Epilepticus
• Super-Refractory Status Epilepticus

Intervention

Drug:
• SAGE-547

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

External Links

•   Link