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NCT02052739 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
A Phase 1 study of Super-refractory Status Epilepticus, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 17
- Study locations
NCT02052739: Completed Phase 1 study of Super-refractory Status Epilepticus, sponsored by Supernus Pharmaceuticals.
NCT02052739 is a Phase 1 study of Super-refractory Status Epilepticus that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02052739, a Phase 1 study of Super-refractory Status Epilepticus, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in participants in super-refractory status epilepticus (SRSE).
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs are defined as those that begin on or after i
Conditions Studied
Interventions
- DRUG SAGE-547
Study Locations (17)
Massachusetts
- Sage Investigational Site - Boston
- Sage Investigational Site - Boston
Michigan
- Sage Investigational Site - Ann Arbor
- Sage Investigational Site - Detroit
New York
- Sage Investigational Site - New York
- Sage Investigational Site - Rochester
North Carolina
- Sage Investigational Site - Durham
- Sage Investigational Site - Winston-Salem
Texas
- Sage Investigational Site - Dallas
- Sage Investigational Site - Temple
Alabama
- Sage Investigational Site - Birmingham
Florida
- Sage Investigational Site - Sarasota
Illinois
- Sage Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-03-21 |
| Est. Completion | 2015-05-03 |
| Phase | Phase 1 |
What the finished NCT02052739 record still lists
NCT02052739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Super-refractory Status Epilepticus appearing as the primary indexed condition, and to 1 intervention - of which SAGE-547 is the first listed.
NCT02052739 lists 17 locations in 12 states (Massachusetts, Michigan, New York).
Frequently Asked Questions
What is clinical trial NCT02052739 about?
NCT02052739 is a clinical study titled "Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus". The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in participants in super-refractory status epilepticus (SRSE).
What is the current status of trial NCT02052739?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2014-03-21. Estimated completion is 2015-05-03.
What conditions does trial NCT02052739 study?
This clinical trial studies the following conditions: Super-refractory Status Epilepticus.
What interventions are being tested in trial NCT02052739?
The interventions under investigation include: SAGE-547 (DRUG).
Who is sponsoring clinical trial NCT02052739?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02052739 being conducted?
This trial has 17 study locations across Alabama, Florida, Illinois, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02052739's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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