BIP_Sage PSV 547-SSE-301
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
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).
-Failed to respond to the administration of at least one first-line agent.
-Failed to respond to at least one second-line agent.
-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 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 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.
-Subjects with Super-Refractory Status Epilepticus due to anoxic/hypoxic encephalopathy.
-Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Tomoko Sampson MD
- Providence St. Vincent Medical Center