Observational Study of LUMRYZ in Narcolepsy (REFRESH)

A Prospective, Multicenter, Observational Study of LUMRYZ Used in Clinical Practice for the Treatment of Narcolepsy

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.

Study Overview

• Status: Completed
• Conditions: Narcolepsy
• Intervention / Treatment: Drug: LUMRYZ

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34209
      • Jeremy D McConnell, MD PA
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • Comprehensive Sleep Center
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • Patient First MD
  • New York
    • East Syracuse, New York, United States, 13057
      • Ghaly Sleep Management Services
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates
    • Wynnewood, Pennsylvania, United States, 19096
      • Pulmonology Associates, Inc.
    • Wyomissing, Pennsylvania, United States, 19610
      • Respiratory Specialists
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants
  • Texas
    • Sugar Land, Texas, United States, 77478
      • Tricoastal Narcolepsy and Sleep Disorder Center
    • Tomball, Texas, United States, 77375
      • Northwest Houston Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (18 years and older) with a diagnosis of Type 1 or Type 2 narcolepsy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients Starting LUMRYZ; The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician.	Drug: LUMRYZ; Prescribed for narcolepsy in accordance with product label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Avadel

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): October 28, 2025

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: PMLUM-2402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No