A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy

April 1, 2022 updated by: Jazz Pharmaceuticals

Nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. It is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy, with follow-up every six months.

Nexus website: www.narcolepsyregistry.com

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Jazz Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients with narcolepsy

Description

Inclusion Criteria:

  • 18 years or older
  • Diagnosed with narcolepsy by a doctor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive epidemiology of type 1 and type 2 narcolepsy
Time Frame: Participants complete a survey every 6 months for 3 years after enrollment
Assessments include disease/diagnosis characteristics, disease/symptom characteristics, health-related quality of life (HRQoL), functioning, work productivity, resource utilization, and comorbidity burden at the time of enrollment and their progression through the course of the study
Participants complete a survey every 6 months for 3 years after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication utilization and treatment outcomes for type 1 and type 2 narcolepsy
Time Frame: Participants complete a survey every 6 months for 3 years after enrollment
Assessments include: Medication use, non-pharmacologic disease management, symptom relief, quality of life (QoL), functionality and productivity associated with varying treatment regimens at baseline and their change throughout the course of the study
Participants complete a survey every 6 months for 3 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Collaborators

ICON plc
Invitae Corporation
Wake Up Narcolepsy
Narcolepsy Network

Investigators

  • Study Director: Danielle Hyman, PhD, Jazz Pharmaceuticals
  • Principal Investigator: JeanPierre Coaquira, MPH, Jazz Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 8, 2015

Primary Completion (ACTUAL)

August 9, 2021

Study Completion (ACTUAL)

August 9, 2021

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (ESTIMATE)

May 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nexus Narcolepsy Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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