Observational Study of LUMRYZ in Narcolepsy

Active, not recruiting

• Conditions: Narcolepsy
• Interventions: Drug: LUMRYZ

• 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

Study Timeline

• Study Start: 2024-07-18
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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 & 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)

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