Campus Construction Update

Starting September 14, we’re closing the Menino building lobby entrance. This, along with the ongoing Yawkey building entrance closure, will help us bring you an even better campus experience that matches the exceptional care you've come to expect. Please enter the Menino and Yawkey buildings through the Moakley building, and make sure to leave extra time to get to your appointment. Thank you for your patience. 

Click here to learn more about our campus redesign. 

SAGE 547-301: A Phase 3 Randomized Clinical Trial to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects with Super-Refractory Status Epilepticus

Sponsor: Sage Therapeutics
Principal Investigator: Anna Cervantes-Arslanian MD
Sub-Investigators: Courtney Takahashi MD, Melissa Mercado MD, Ayshe Ana Beesen MD, Maria Stefanidou MD

Summary

To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in adult and pediatric subjects with SRSE, and for the response to endure at least 24 hours after the end of the SAGE-547 or placebo infusion (primary response).

Inclusion Criteria:

  1. 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;
  2. 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;
  3. 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 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 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 suppression pattern.