At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 132 enrolled
Drug / intervention
SAGE-547 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SAGE-547 and Placebo for Super-Refractory Status Epilepticus. Completed, enrolled 132 participants across 171 sites in 16 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuper-Refractory Status Epilepticus
CountriesAustria, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionJul 2017
Study CompletionAug 2017
TodayJul 2026
First PostedJun 23, 2015
Enrollment StartJun 1, 2015
Primary CompletionJul 18, 2017
Study CompletionAug 11, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.0 years ago
Interventions
SAGE-547drug
Placebodrug
Placebo