Observational Study of LUMRYZ in Narcolepsy

NCT ID: NCT06792708

Last Updated: 2026-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-18

Study Completion Date

2025-10-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Narcolepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients Starting LUMRYZ

The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician.

LUMRYZ

Intervention Type DRUG

Prescribed for narcolepsy in accordance with product label.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LUMRYZ

Prescribed for narcolepsy in accordance with product label.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Avadel

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jeremy D McConnell, MD PA

Bradenton, Florida, United States

Site Status

Comprehensive Sleep Center

East Lansing, Michigan, United States

Site Status

Patient First MD

Middletown, New Jersey, United States

Site Status

Ghaly Sleep Management Services

East Syracuse, New York, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Ohio Sleep Medicine Institute

Dublin, Ohio, United States

Site Status

Abington Neurological Associates

Abington, Pennsylvania, United States

Site Status

Pulmonology Associates, Inc.

Wynnewood, Pennsylvania, United States

Site Status

Respiratory Specialists

Wyomissing, Pennsylvania, United States

Site Status

Bogan Sleep Consultants

Columbia, South Carolina, United States

Site Status

Tricoastal Narcolepsy and Sleep Disorder Center

Sugar Land, Texas, United States

Site Status

Northwest Houston Neurology

Tomball, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PMLUM-2402

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Auditory Midbrain Implant Study
NCT02984202 COMPLETED NA
OTO-313 in Subjects With Subjective Tinnitus
NCT03918109 COMPLETED PHASE1/PHASE2