Observational Study of LUMRYZ in Narcolepsy
REFRESH
A Prospective, Multicenter, Observational Study of LUMRYZ Used in Clinical Practice for the Treatment of Narcolepsy
1 other identifier
observational
71
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2024
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2024
CompletedFirst Submitted
Initial submission to the registry
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2025
CompletedFebruary 13, 2026
February 1, 2026
1.3 years
January 20, 2025
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (5)
Narcolepsy Severity Scale
Baseline to Month 4
Sheehan Disability Scale
Baseline to Month 4
Patient Global Impression of Change
Month 4
- +2 more other outcomes
Study Arms (1)
Patients Starting LUMRYZ
The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician.
Interventions
Eligibility Criteria
Adults (18 years and older) with a diagnosis of Type 1 or Type 2 narcolepsy
You may qualify if:
- 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
You may not qualify if:
- Already using LUMRYZ
- Clinical or mental health condition excluded by LUMRYZ label
- Any other condition/situation that would adversely impact participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avadellead
Study Sites (12)
Jeremy D McConnell, MD PA
Bradenton, Florida, 34209, United States
Comprehensive Sleep Center
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2025
First Posted
January 27, 2025
Study Start
July 18, 2024
Primary Completion
October 28, 2025
Study Completion
October 28, 2025
Last Updated
February 13, 2026
Record last verified: 2026-02