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NCT02477618 · ClinicalTrials.gov registry record · Phase 3
A Study With SAGE-547 for Super-Refractory Status Epilepticus
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
NCT02477618: Completed Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT02477618 is a Phase 3 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02477618, a Phase 3 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG SAGE-547
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-08-11 |
| Phase | Phase 3 |
What the finished NCT02477618 record still lists
NCT02477618 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02477618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02477618 about?
NCT02477618 is a clinical study titled "A Study With SAGE-547 for 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).
What is the current status of trial NCT02477618?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2015-06. Estimated completion is 2017-08-11.
What interventions are being tested in trial NCT02477618?
The interventions under investigation include: Placebo (DRUG), SAGE-547 (DRUG).
Who is sponsoring clinical trial NCT02477618?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02477618's enrollment target sits among peer trials
132 1588th of 2000 higher than 408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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