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NCT02221869 · ClinicalTrials.gov registry record · Phase 3
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
A Phase 3 study of Narcolepsy With Cataplexy, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT02221869 is a Phase 3 study of Narcolepsy With Cataplexy that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 106 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT02221869, a Phase 3 study of Narcolepsy With Cataplexy, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
Conditions Studied
Interventions
- DRUG Xyrem
Study Locations (20)
California
- Miller Children's Hospital - Long Beach - Long Beach
- SDS Clinical Trials, Inc. - Orange
- Stanford Sleep Medicine Center - Redwood City
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- University Hospitals Cleveland Medical Center - Cleveland
- Nationwide Children's Hospital - Columbus
North Carolina
- Duke Children's Hospital - Durham
- ARSM Research, LLC - Huntersville
South Carolina
- SleepMed of SC - Columbia
- Greenville Health System - Greenville
Other
- Hospital Robert Debre - Paris
- Dipartimento di Scienze Biomediche e Biomotorie - Bologna
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Michigan
- The U-M Sleep Disorders Center - Ann Arbor
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2019-01-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02221869
The ClinicalTrials.gov registry entry for NCT02221869 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Narcolepsy With Cataplexy appearing as the primary indexed condition, and to 1 intervention - of which Xyrem is the first listed.
NCT02221869 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Ohio, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02221869 about?
NCT02221869 is a clinical study titled "A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy". The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
What is the current status of trial NCT02221869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2014-10-01. Estimated completion is 2019-01-25.
What conditions does trial NCT02221869 study?
This clinical trial studies the following conditions: Narcolepsy With Cataplexy.
What interventions are being tested in trial NCT02221869?
The interventions under investigation include: Xyrem (DRUG).
Who is sponsoring clinical trial NCT02221869?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02221869 being conducted?
This trial has 20 study locations across California, Illinois, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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