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
- Conditions
- Epilepsyepilepsyseizures10039911
- Registration Number
- NL-OMON43720
- Lead Sponsor
- SAGE Therapeutics
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Success or failure, with success defined as weaning the subject off all<br /><br>third-line agents before completion of the first blinded infusion of SAGE-547<br /><br>or placebo, and not having to re-institute any third-line agent for seizure or<br /><br>burst suppression during the 24 hours after the end of the first infusion of<br /><br>SAGE-547 or placebo, and concurrent signs of physiologic brain activity as<br /><br>determined by EEG (primary response).</p><br>
- Secondary Outcome Measures
Name Time Method