NL-OMON43720
Completed
Phase 3
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS - STATUS trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- SAGE Therapeutics
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects 18 years of age and older.
- •2\. 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 institution 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 AED), according to institution 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 or more wean attempts from third\-line agents and are now on continuous intravenous infusions of one or more third\-line agent 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 a continuous intravenous infusion of at least one third\-line agent or are on a continuous intravenous infusion of one or more third\-line agent but not in an EEG burst or seizure suppression pattern.
Exclusion Criteria
- •1\. Subjects who are pregnant.
- •2\. Subjects with a known allergy to progesterone or allopregnanolone or any excipients in SAGE\-547\.
- •3\. Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/malignant EEG features (Westhall, Rosetti et al. 2016\).
- •4\. Subjects who have any of the following: a. a GFR low enough to warrant dialysis but for whatever reason, dialysis that would adequately remove Captisol® is not planned; b. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third\-line agent use; c. fulminant hepatic failure; d. no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life\-expectancy, in the opinion of the investigator, of less than 30 days;
- •5\. Subjects who are being administered more than three third\-line agents concomitantly or in whom the qualifying wean cannot be completed within 24 hours, or who are being administered a third\-line agent for other indications such as management of raised intra\-cranial pressure that would preclude weaning according to this protocol.
- •6\. Subjects with a living will that does not allow heroic measures.
- •7\. Subjects who have been exposed to an investigational medication or device within 30 days; the exception to this is that participation in the Established Status Epilepticus Treatment Trial or ESETT within 30 days of screening for the 547\-SSE\-301 trial is allowed.
- •8\. Subjects who have been treated or randomized in this trial or any other trial employing SAGE\-547 previously (i.e., subjects may not have received study drug/placebo and then re\-enroll).
Outcomes
Primary Outcomes
Not specified
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