Narcolepsy Clinical Trial
Official title:
The Patient Voice in Narcolepsy Clinical Trials: Reflections on Experiences and Outcomes
| NCT number | NCT05870735 |
| Other study ID # | 90685891 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2024 |
| Est. completion date | June 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | June 2026 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
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. — View Citation
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. — View Citation
Leschziner G. Narcolepsy: a clinical review. Pract Neurol. 2014 Oct;14(5):323-31. doi: 10.1136/practneurol-2014-000837. Epub 2014 May 15. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patients who decide to enroll in a narcolepsy clinical study. | 3 months | ||
| Primary | Number of narcolepsy study participants who remain in clinical trial until completion. | 12 months |
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