Important Announcements

Nondiscrimination Statement Update

Boston Medical Center Health System complies with applicable Federal civil rights laws and does not discriminate on the basis of age, race, color, national origin (including limited English proficiency and primary language), religion, culture, physical or mental disabilities, socioeconomic status, sex, sexual orientation and gender identity and/or expression. BMCHS provides free aids and services to people with disabilities and free language services to people whose primary language is not English.

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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 547-302

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SAGE 547-302: To Evaluate Open-Label Use of SAGE-547 (Allopregnanolone) in the Treatment of Subjects with Super-Refractory Status Epilepticus

Supported by: SAGE

Principal Investigator at BMC: Anna Cervantes-Arslanian, MD

Inclusion Criteria:

Subjects who have:

  1. Failed to respond to the administration of at least one first-line agent (eg, benzodiazepine or other emergent initial AED treatment), according to the institution’s standard of care, and;
  2. Failed to respond to at least one second-line agent (eg, phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam, or other urgent control AEDs), according to the institution’s standard of care, and;
  3. Not previously been administered a third-line agent, but have been admitted to an ICU 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 agents 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 at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents, but not in an EEG burst suppression pattern.

Exclusion Criteria: 

  1. Subjects who are pregnant;
  2. Subjects with a known allergy to progesterone or allopregnanolone or any excipients in SAGE-547;
  3. Subjects with SRSE due to anoxic/hypoxic encephalopathy;
  4. Subjects who have any of the following:
    a.    GFR low enough to warrant dialysis but for whatever reason, dialysis that would adequately remove Captisol is not planned;
    b.    Severe cardiogenic or vasodilatory shock requiring 2 or more pressors that is not related to third-line agent use;
    c.    Fulminant hepatic failure;
    d.    No reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the opinion of the investigator, of less than 30 days;
    e.    Do not resuscitate (DNR) order;
  5. Subjects who are being administered more than 3 third-line agents concomitantly or in whom the qualifying wean cannot be completed within 24 hours; or who are being administered a third-line agent for other indications such as raised intra-cranial pressure that would preclude weaning according to this protocol;
  6. Subjects with a living will that does not allow heroic measures;
  7. Subjects who have been exposed to an investigational medication or device within 30 days; the exception to this is that participation in the Established Status Epilepticus Treatment Trial or ESETT within 30 days of screening for Study 547-SSE-302 is allowed;
  8. Subjects who have been treated with study drug or randomized in this or any other trial employing SAGE-547 previously;
  9. Subjects for whom it is not medically feasible to be transferred to a geographically accessible participating clinical trial site for Study 547-SSE-301.