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
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).
Inclusion Criteria:
Subjects two (2) years of age and older
Subjects who have:
Exclusion Criteria:
Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
Children (subjects aged less than 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder
Subjects who have any of the following:
Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol
Norfolk, NR4 7UY, United Kingdom
Staffordshire, ST3 6QG, United Kingdom