Trials / Completed
CompletedNCT02477618
A Study With SAGE-547 for 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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAGE-547 | |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2017-07-18
- Completion
- 2017-08-11
- First posted
- 2015-06-23
- Last updated
- 2025-10-14
- Results posted
- 2019-05-02
Locations
171 sites across 16 countries: United States, Austria, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02477618. Inclusion in this directory is not an endorsement.