Discovering Factors in Narcolepsy Patients' Clinical Research Experiences
The Patient Voice in Narcolepsy Clinical Trials: Reflections on Experiences and Outcomes
1 other identifier
observational
500
0 countries
N/A
Brief Summary
An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs. Overall, an observational clinical trial is an important tool for advancing the understanding of narcolepsy and improving outcomes for patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 23, 2023
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedMay 23, 2023
May 1, 2023
1 year
May 12, 2023
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of patients who decide to enroll in a narcolepsy clinical study.
3 months
Number of narcolepsy study participants who remain in clinical trial until completion.
12 months
Eligibility Criteria
Patients who are actively considering involvement in an observational narcolepsy trial, but have not yet completed enrollment and registration.
You may qualify if:
- Patient is at least 18 years of age
- Patient is able and willing to comply with the treatment/follow-up schedule and requirements
- Patient must provide written informed consent
You may not qualify if:
- Women who are pregnant, intend to become pregnant, or are lactating
- Inability to perform regular electronic reporting
- Participants who are vulnerable to any intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.
PMID: 36098936BACKGROUNDBassetti CLA, Adamantidis A, Burdakov D, Han F, Gay S, Kallweit U, Khatami R, Koning F, Kornum BR, Lammers GJ, Liblau RS, Luppi PH, Mayer G, Pollmacher T, Sakurai T, Sallusto F, Scammell TE, Tafti M, Dauvilliers Y. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519-539. doi: 10.1038/s41582-019-0226-9. Epub 2019 Jul 19.
PMID: 31324898BACKGROUNDLeschziner G. Narcolepsy: a clinical review. Pract Neurol. 2014 Oct;14(5):323-31. doi: 10.1136/practneurol-2014-000837. Epub 2014 May 15.
PMID: 24830461BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael B Gill
Power Life Sciences Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
May 23, 2023
Study Start
June 1, 2024
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
May 23, 2023
Record last verified: 2023-05