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This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ. The questionnaires ask about narcolepsy symptoms, experience with LUMRYZ, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Starting LUMRYZ | The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUMRYZ | Drug | Prescribed for narcolepsy in accordance with product label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale | Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of sleepiness with total possible score of 0-24 (higher score equivalent to higher sleepiness) | Baseline to Month 4 |
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| Measure | Description | Time Frame |
|---|---|---|
| Narcolepsy Severity Scale | Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of narcolepsy symptom frequency and impact on daily life with total possible score from 0-57 (higher score indicates more frequent and severe symptoms) | Baseline to Month 4 |
| Sheehan Disability Scale |
Inclusion Criteria:
Exclusion Criteria:
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Adults (18 years and older) with a diagnosis of Type 1 or Type 2 narcolepsy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeremy D McConnell, MD PA | Bradenton | Florida | 34209 | United States | ||
| Comprehensive Sleep Center |
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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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Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of disruption to normal activities using a 0-10 scale, along with the number of days missed and/or underproductive at work/school |
| Baseline to Month 4 |
| Patient Global Impression of Change | Measure of improvement at Month 4 using a scale of 1 (very much improved) to 7 (very much worse); scored by patient | Month 4 |
| Clinical Global Impression of Change | Measure of improvement at Month 4 using a scale of 1 (very much improved) to 7 (very much worse); scored by clinician | Month 4 |
| Adverse Reactions | Clinician-directed interview for common adverse reactions | Month 1, Month 2, Month 3, Month 4 |
| East Lansing |
| Michigan |
| 48823 |
| United States |
| Patient First MD | Middletown | New Jersey | 07748 | United States |
| Ghaly Sleep Management Services | East Syracuse | New York | 13057 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | United States |
| Pulmonology Associates, Inc. | Wynnewood | Pennsylvania | 19096 | United States |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | United States |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | United States |
| Tricoastal Narcolepsy and Sleep Disorder Center | Sugar Land | Texas | 77478 | United States |
| Northwest Houston Neurology | Tomball | Texas | 77375 | United States |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |