NarcolepsyNCT02769780
A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
An observational study of Narcolepsy, run by Jazz Pharmaceuticals at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2015to 9 Aug 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with narcolepsy
Who may be able to join
- 18 years or older
- Diagnosed with narcolepsy by a doctor
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Narcolepsy
- Medical subject headings
- Narcolepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Participants complete a survey every 6 months for 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start8 Jul 2015
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Invitae Corporation, Wake Up Narcolepsy, Narcolepsy Network, ICON plc
- Responsible party
- Sponsor
- Investigators
- Danielle Hyman, PhD, Study director, Jazz PharmaceuticalsJeanPierre Coaquira, MPH, Principal investigator, Jazz Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769780
- Sponsor's protocol ID
- Nexus Narcolepsy Registry
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2016
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34247126
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
- ClinicalTrials.gov ID
- NCT02769780
- Acronym / sponsor ID
- Nexus Narcolepsy Registry
- Conditions
- Narcolepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Invitae Corporation, Wake Up Narcolepsy, Narcolepsy Network, ICON plc
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with narcolepsy
Key inclusion criteria (2 listed)
- 18 years or older
- Diagnosed with narcolepsy by a doctor
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 34247126Thorpy 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Hyman, PhD study director
Jazz Pharmaceuticals
JeanPierre Coaquira, MPH principal investigator
Jazz Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy, run by Jazz Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive epidemiology of type 1 and type 2 narcolepsy (time frame: Participants complete a survey every 6 months for 3 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.