This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression electroencephalogram (EEG) pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion and remain off all third-line agents for \>=24 hours after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
Time frame: 7 days
Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion and remain off all third-line agents for \>=24 hours after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
Time frame: Up to 21 days
Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sage Investigational Site
Birmingham, Alabama, United States
Sage Investigational Site
Mobile, Alabama, United States
Sage Investigational Site
Phoenix, Arizona, United States
Sage Investigational Site
Phoenix, Arizona, United States
Sage Investigational Site
Little Rock, Arkansas, United States
Sage Investigational Site
Fresno, California, United States
Sage Investigational Site
Loma Linda, California, United States
Sage Investigational Site
Los Angeles, California, United States
Sage Investigational Site
Roseville, California, United States
Sage Investigational Site
Sacramento, California, United States
...and 161 more locations
Time frame: Day 6
Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
Time frame: Up to 21 days
Change in Clinical Global Impression Scale (CGI)
The CGI scale was used to integrate several sources of information into a single rating of a participant's condition. The CGI was rated on a 7-point scale, from a minimum of 0 to a maximum of 7, where 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline physically ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill participants. A negative change from baseline indicates improvement. A positive change from baseline indicates worsening. Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time frame: Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time frame: Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time frame: Up to 21 days
Number of Separate Episodes of Status Epilepticus Up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time frame: Up to 21 days
Number of Participants With a New Diagnosis of Epilepsy After Visit 11
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Time frame: Up to 21 days