A Study With SAGE-547 for Super-Refractory Status Epilepticus
Sponsored by Sage Therapeutics
About this trial
Last updated 3 years ago
Study ID
547-SSE-301
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
Yes
Accepting
2+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 8 years ago
What is this trial about?
This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the
efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to
subjects in Super-Refractory Status Epilepticus (SRSE).
What are the participation requirements?
Inclusion Criteria
- Subjects two (2) years 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 anti-epileptic drug [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, one 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
- Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
- Children (subjects aged less than 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder
- Subjects who have any of the following:
1. a glomerular filtration rate (GFR) low enough to warrant dialysis but for whatever reason, dialysis is not planned or non-continuous dialysis planned (that would not adequately remove Captisol®);
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 (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is 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
View clinical trial results on registries
For more information, view the full study details:
NCT02477618