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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are actively considering involvement in an observational narcolepsy trial, but have not yet completed enrollment and registration.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Gill | Contact | 415-900-4227 | bask@withpower.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael B Gill | Power Life Sciences Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36098936 | Background | 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. | |
| 31324898 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 12, 2023 | May 12, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| 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. |
| 24830461 | Background | Leschziner G. Narcolepsy: a clinical review. Pract Neurol. 2014 Oct;14(5):323-31. doi: 10.1136/practneurol-2014-000837. Epub 2014 May 15. |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |