Discovering Factors in Narcolepsy Patients' Clinical Research Experiences
Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05870735
Collaborator
(none)
500
24
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
The Patient Voice in Narcolepsy Clinical Trials: Reflections on Experiences and Outcomes
Anticipated Study Start Date
:
Jun 1, 2024
Anticipated Primary Completion Date
:
Jun 1, 2025
Anticipated Study Completion Date
:
Jun 1, 2026
Outcome Measures
Primary Outcome Measures
- 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
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Women who are pregnant, intend to become pregnant, or are lactating
-
Inability to perform regular electronic reporting
-
Participants who are vulnerable to any intervention
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Study Documents (Full-Text)
More Information
Publications
- Bassetti 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.
- 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.
- Leschziner G. Narcolepsy: a clinical review. Pract Neurol. 2014 Oct;14(5):323-31. doi: 10.1136/practneurol-2014-000837. Epub 2014 May 15.
Responsible Party:
Power Life Sciences Inc.
ClinicalTrials.gov Identifier:
NCT05870735
Other Study ID Numbers:
- 90685891
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Power Life Sciences Inc.
Additional relevant MeSH terms: