Narcolepsy
Conditions
Brief summary
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.
Interventions
DRUGLUMRYZ
Prescribed for narcolepsy in accordance with product label.
Sponsors
Avadel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with narcolepsy * Oxybate naive or prior treatment with twice-nightly oxybate * Access to smart phone, tablet or laptop with reliable internet connection * Able to read/understand English * Written informed consent and ability to comply with schedule
Exclusion criteria
* Already using LUMRYZ * Clinical or mental health condition excluded by LUMRYZ label * Any other condition/situation that would adversely impact participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale | Baseline to Month 4 | 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) |
Countries
United States
Outcome results
None listed