NarcolepsyREFRESHNCT06792708
Observational Study of LUMRYZ in Narcolepsy
An observational study of Narcolepsy, run by Avadel at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy
- What is being tested?
- LUMRYZ
- How many people
- 71 participants
- Where
- 12 sitesUnited States
- Study dates
- 18 Jul 2024to 28 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (18 years and older) with a diagnosis of Type 1 or Type 2 narcolepsy
Who may be able to join
- 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
Who cannot join
- Already using LUMRYZ
- Clinical or mental health condition excluded by LUMRYZ label
- Any other condition/situation that would adversely impact participation
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Abington Neurological Associates
Abington, Pennsylvania, 19001
Jeremy D McConnell, MD PA
Bradenton, Florida, 34209
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Bogan Sleep Consultants
Columbia, South Carolina, 29201
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Comprehensive Sleep Center
East Lansing, Michigan, 48823
Ghaly Sleep Management Services
East Syracuse, New York, 13057
Patient First MD
Middletown, New Jersey, 07748
Tricoastal Narcolepsy and Sleep Disorder Center
Sugar Land, Texas, 77478
Northwest Houston Neurology
Tomball, Texas, 77375
Pulmonology Associates, Inc.
Wynnewood, Pennsylvania, 19096
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
About this study
Official title: 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.
- Conditions
- Narcolepsy
- Being tested
- LUMRYZ
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUMRYZDrug
Prescribed for narcolepsy in accordance with product label.
| Study group | Role | What they receive |
|---|---|---|
| Patients Starting LUMRYZ | The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician. Receives: Drug: LUMRYZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start18 Jul 2024
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avadel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792708
- Sponsor's protocol ID
- PMLUM-2402
- Acronym
- REFRESH
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study of LUMRYZ Used in Clinical Practice for the Treatment of Narcolepsy
- ClinicalTrials.gov ID
- NCT06792708
- Acronym / sponsor ID
- REFRESH / PMLUM-2402
- Conditions
- Narcolepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- AvadelIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Starting LUMRYZ | – | Drug: LUMRYZThe cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18 years and older) with a diagnosis of Type 1 or Type 2 narcolepsy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Already using LUMRYZ
- Clinical or mental health condition excluded by LUMRYZ label
- Any other condition/situation that would adversely impact participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUMRYZPrescribed for narcolepsy in accordance with product label. | Drug | Patients Starting LUMRYZ |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy, run by Avadel at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale (time frame: Baseline to Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.