ClinicalTrials.gg
CompletedNCT06792708REFRESHUpdated Feb 13, 2026

Observational Study of LUMRYZ in Narcolepsy

An observational study in Narcolepsy, sponsored by Avadel. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Avadel (part of Alkermes, Inc.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
71
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Narcolepsy

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03

In context

Narcolepsy

157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.

This study's enrollment of 71 is below the median of 135 across 38 observational studies indexed under Narcolepsy.

Browse Narcolepsy studies →

Lead sponsor

Avadel is the lead sponsor of 4 studies on the registry; none are open to participants now.

First submitted before Avadel became part of Alkermes, Inc..

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and ability to comply with schedule

Exclusion criteria

Exclusion Criteria:

  • Already using LUMRYZ
  • Clinical or mental health condition excluded by LUMRYZ label
  • Any other condition/situation that would adversely impact participation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
71 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients Starting LUMRYZ

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

    Drug: LUMRYZ

Interventions

  • DrugLUMRYZ

    Prescribed for narcolepsy in accordance with product label.

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What researchers measure

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)

    Time frame: Baseline to Month 4

Other outcomes

  1. 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)

    Time frame: Baseline to Month 4

  2. 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

    Time frame: Baseline to Month 4

  3. 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

    Time frame: Month 4

  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

    Time frame: Month 4

  5. Adverse Reactions

    Clinician-directed interview for common adverse reactions

    Time frame: Month 1, Month 2, Month 3, Month 4

07

Study locations

12 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06792708
Lead sponsor
Avadel
Responsible party
Sponsor
First posted
Jan 27, 2025
Start date
Jul 18, 2024
Primary completion
Oct 28, 2025
Completion
Oct 28, 2025
Last update
Feb 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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