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:
Jazz Pharmaceuticals
Collaborators:
Invitae Corporation
Wake Up Narcolepsy
Narcolepsy Network
ICON plc
Information provided by (Responsible Party):
Jazz Pharmaceuticals
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | March 9, 2016 | ||||||
| First Posted Date | May 12, 2016 | ||||||
| Last Update Posted Date | April 5, 2022 | ||||||
| Actual Study Start Date | July 8, 2015 | ||||||
| Actual Primary Completion Date | August 9, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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
|
||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
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
|
||||||
| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy | ||||||
| Official Title | A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy | ||||||
| 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 |
||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | 6 Months | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | All adult patients with narcolepsy | ||||||
| Condition | Narcolepsy | ||||||
| Intervention | Not Provided | ||||||
| Study Groups/Cohorts | Not Provided | ||||||
| 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. | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
1500 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Actual Study Completion Date | August 9, 2021 | ||||||
| Actual Primary Completion Date | August 9, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria:
|
||||||
| Sex/Gender |
|
||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT02769780 | ||||||
| Other Study ID Numbers | Nexus Narcolepsy Registry | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement |
|
||||||
| Current Responsible Party | Jazz Pharmaceuticals | ||||||
| Original Responsible Party | Same as current | ||||||
| Current Study Sponsor | Jazz Pharmaceuticals | ||||||
| Original Study Sponsor | Same as current | ||||||
| Collaborators |
|
||||||
| Investigators |
|
||||||
| PRS Account | Jazz Pharmaceuticals | ||||||
| Verification Date | April 2022 | ||||||