The STATUS Trial

Clinical Trial Title

The 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.

Study Details

Clinical Trial Investigator

Sebastian Pollandt, MD

Contact Information

Raquel Garcia-Cano

(312) 563-2741