Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Narcolepsy With Cataplexy, sponsored by Jazz Pharmaceuticals.
NCT02221869 is a Phase 3 study of Narcolepsy With Cataplexy that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Double-blind comparison of the change in weekly number of cataplexy attacks from the last 2 weeks of the Stable Dose Period to the 2 weeks of the Double-blind Treatment Period.
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 |
What the finished NCT02221869 record still lists
NCT02221869 is an interventional study that assigns participants to a tested intervention. The registered 106 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 (86% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Narcolepsy With Cataplexy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02221869's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03181048 · 106 participants · NA
Clinical Trial of Concomitant Hip Arthroscopy During PAO
- NCT04682158 · 106 participants · Phase 2
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
- NCT04724018 · 106 participants · Phase 1
Sacituzumab Govitecan Plus EV in Metastatic UC
- NCT04798274 · 106 participants · NA
Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI