NCT02769780

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2021

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

6.1 years

First QC Date

March 9, 2016

Last Update Submit

April 1, 2022

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (1)

  • Descriptive epidemiology of type 1 and type 2 narcolepsy

    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 Outcomes (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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients with narcolepsy

You may qualify if:

  • years or older
  • Diagnosed with narcolepsy by a doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jazz Pharmaceuticals

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Thorpy MJ, Ohayon MM, Carls G, Black J, Pasta DJ, Hyman DL, Villa KF. Assessing the impact of sodium oxybate treatment on functioning, productivity, and health-related quality of life in patients with narcolepsy: findings from the Nexus Narcolepsy Registry (waves 1-4). Sleep Med. 2021 Aug;84:380-388. doi: 10.1016/j.sleep.2021.06.010. Epub 2021 Jun 19.

    PMID: 34247126DERIVED

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Danielle Hyman, PhD

    Jazz Pharmaceuticals

    STUDY DIRECTOR

  • JeanPierre Coaquira, MPH

    Jazz Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

May 12, 2016

Study Start

July 8, 2015

Primary Completion

August 9, 2021

Study Completion

August 9, 2021

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

US(1)