Clincosm LogoSign in Get a demo

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

Sponsor
Jazz Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02769780
Collaborator
Invitae Corporation (Industry), Wake Up Narcolepsy (Other), Narcolepsy Network (Other), ICON plc (Industry)
1,500
Enrollment
1
Location
73.1
Actual Duration (Months)
20.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
    Actual Study Start Date :
    Jul 8, 2015
    Actual Primary Completion Date :
    Aug 9, 2021
    Actual Study Completion Date :
    Aug 9, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Descriptive epidemiology of type 1 and type 2 narcolepsy [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

    Secondary Outcome Measures

    1. Medication utilization and treatment outcomes for type 1 and type 2 narcolepsy [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years or older

    • Diagnosed with narcolepsy by a doctor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jazz Pharmaceuticals Palo Alto California United States 94304

    Sponsors and Collaborators

    • Jazz Pharmaceuticals
    • Invitae Corporation
    • Wake Up Narcolepsy
    • Narcolepsy Network
    • ICON plc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jazz Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02769780
    Other Study ID Numbers:
    • Nexus Narcolepsy Registry
    First Posted:
    May 12, 2016
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Narcolepsy

    Study Results

    No Results Posted as of Apr 5, 2022