Observational Study of LUMRYZ in Narcolepsy
- Registration Number
- NCT06792708
- Lead Sponsor
- Avadel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- Already using LUMRYZ
- Clinical or mental health condition excluded by LUMRYZ label
- Any other condition/situation that would adversely impact participation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Starting LUMRYZ LUMRYZ The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician.
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (12)
Jeremy D McConnell, MD PA
🇺🇸Bradenton, Florida, United States
Comprehensive Sleep Center
🇺🇸East Lansing, Michigan, United States
Patient First MD
🇺🇸Middletown, New Jersey, United States
Ghaly Sleep Management Services
🇺🇸East Syracuse, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Ohio Sleep Medicine Institute
🇺🇸Dublin, Ohio, United States
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, United States
Pulmonology Associates, Inc.
🇺🇸Wynnewood, Pennsylvania, United States
Respiratory Specialists
🇺🇸Wyomissing, Pennsylvania, United States
Bogan Sleep Consultants
🇺🇸Columbia, South Carolina, United States
Tricoastal Narcolepsy and Sleep Disorder Center
🇺🇸Sugar Land, Texas, United States
Northwest Houston Neurology
🇺🇸Tomball, Texas, United States