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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769780
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : April 5, 2022
Sponsor:
Collaborators:
Invitae Corporation
Wake Up Narcolepsy
Narcolepsy Network
ICON plc
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Narcolepsy

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
Actual Study Start Date : July 8, 2015
Actual Primary Completion Date : August 9, 2021
Actual Study Completion Date : August 9, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients with narcolepsy
Criteria

Inclusion Criteria:

  • 18 years or older
  • Diagnosed with narcolepsy by a doctor
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769780


Locations
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United States, California
Jazz Pharmaceuticals
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Jazz Pharmaceuticals
Invitae Corporation
Wake Up Narcolepsy
Narcolepsy Network
ICON plc
Investigators
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Study Director: Danielle Hyman, PhD Jazz Pharmaceuticals
Principal Investigator: JeanPierre Coaquira, MPH Jazz Pharmaceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02769780    
Other Study ID Numbers: Nexus Narcolepsy Registry
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders