Clinical Trial TitleThe STATUS trial is 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 (SRSE).
Clinical Trial Protocol Description:
The purpose of this study is to evaluate the efficacy and safety of an investigational medicine compared to placebo for the treatment of super-refractory status epilepticus. This is a multicenter trial seeking to recruit 140 patients. The treatment will be assigned randomly.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment).
- Have failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED.
You will be excluded from the study if any of the following criteria apply to you:
- Have certain medical conditions.
This is a partial list of inclusion and exclusion criteria.