Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Supernus Pharmaceuticals, Inc.
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
