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Completed

NCT Number: NCT06792708

Observational Study of LUMRYZ in 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.

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Key information

Conditions

Narcolepsy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jeremy D McConnell, MD PA, Bradenton, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LUMRYZ

Drug

Prescribed for narcolepsy in accordance with product label.

Primary outcomes

  1. Epworth Sleepiness Scale

    Time frame: 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)

Other outcomes

  1. Narcolepsy Severity Scale

    Time frame: Baseline to Month 4

    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)

  2. Sheehan Disability Scale

    Time frame: Baseline to Month 4

    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

  3. Patient Global Impression of Change

    Time frame: Month 4

    Measure of improvement at Month 4 using a scale of 1 (very much improved) to 7 (very much worse); scored by patient

  4. Clinical Global Impression of Change

    Time frame: Month 4

    Measure of improvement at Month 4 using a scale of 1 (very much improved) to 7 (very much worse); scored by clinician

  5. Adverse Reactions

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

    Clinician-directed interview for common adverse reactions

Sponsors and collaborators

Lead sponsor

Avadel

Industry

Registry information

Official study title

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

Acronym: REFRESH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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