NarcolepsyNCT04803786
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
An observational study of Narcolepsy, run by Jazz Pharmaceuticals at 1 site in United States.
Trial summary
The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the impact of transitioning from Xyrem to Xywav in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Transition from Xyrem to Xywav
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 24 Feb 2022
- 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: Male or female asges 18 years and older with diagnosis of type 1 or type 2 narcolepsy. On an active prescription for Xyrem with stable treatment for at least 2 consecutive months.
Who may be able to join
- Male or female, aged 18 years or older
- Diagnosis of type 1 or type 2 narcolepsy by a physician
- Active prescription for Xyrem with a stable treatment regimen for at least 2 consecutive months
- Transitioning from Xyrem to Xywav within the next or past 7 days (- 7 days or + 7 days from the first dose of Xywav)
- Able to read and understand English
- Able to access to a computer/smart phone with internet connection
Show all 9Show fewer
- Not currently a Jazz Pharmaceuticals employees or an immediate family member of a Jazz employee
- Willing and able to comply with the study schedule
- Willing and able to provide electronically written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jazz Pharmaceuticals Clinical Site
Palo Alto, California, 94304
About this study
Official title: Transition Experience of Persons With Narcolepsy Taking Oxybate in the Real-world (TENOR): A Patient-Centric, Prospective, Observational, Non-Interventional Study to Assess Dosing Regimen in Persons Switching From Xyrem to Xywav for the Treatment of Narcolepsy
The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the impact of transitioning from Xyrem to Xywav in a real-world setting.
- Conditions
- Narcolepsy
- Being tested
- Transition from Xyrem to Xywav
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition from Xyrem to XywavDrug
This is a single-group non-interventional study where participant's transitioning from Xyrem to Xywav will be observed. Investigational product (IP) or drug support or requested changes to their medication will not be provided to participants by Jazz Pharmaceuticals. The Xyrem and Xywav that the participants will take will be provided by the participant's health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Transition from Xyrem to Xywav | Not described Receives: Drug: Transition from Xyrem to Xywav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav
- Difference between usual Xyrem total nightly dose and initial prescribed total nightly Xywav dose.
Measured: Baseline to 21 Weeks
Secondary outcomes (2)
Number Prescribed Dose Adjustments of Xywav
The number of dosing adjustments per participants and number of participants with one or more dosing adjustments during the Xywav Treatment Period (Period 2 to 5) by treating physician (dosing amount or number of nightly doses), details of adjustment, reason for adjustment and reason for unequal dosing will be summarized.
Measured: Baseline to 21 Weeks
Duration of Time Between the Last Meal Relative to Dosing
Timing and type of last meal prior to the first dose will be collected using both Daily Diary and Weekly Lookback of Daily Diary. The timing will be collected as actual time (HH:MM) from Daily Diary and as categorical data of usual number of hours relative to first dose (<0.5 hours, ≥0.5 but <1 hours, ≥1 but <1.5 hours, ≥1.5 but <2 hours, ≥2 hours) from Weekly Lookback of Daily Diary. In order to evaluate the timing of last meal across all study periods, the Daily Diary entry will be converted into categorical data using the same value scale as Weekly Lookback of Daily Diary. The type of last meal prior to the first dose will be collected as categorical data (regular meal, snack, and beverage). For both timing and type of last meal prior to the first dose, the number of participants with each response will be summarized.
Measured: Baseline to 21 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start9 Apr 2021
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
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.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803786
- Sponsor's protocol ID
- JZP258-402
- Status last verified
- Jun 2022
- First submitted
- 9 Mar 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition Experience of Persons With Narcolepsy Taking Oxybate in the Real-world (TENOR): A Patient-Centric, Prospective, Observational, Non-Interventional Study to Assess Dosing Regimen in Persons Switching From Xyrem to Xywav for the Treatment of Narcolepsy
- ClinicalTrials.gov ID
- NCT04803786
- Acronym / sponsor ID
- JZP258-402
- Conditions
- Narcolepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 18 Mar 2021 (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.
The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the impact of transitioning from Xyrem to Xywav in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transition from Xyrem to Xywav | – | Drug: Transition from Xyrem to Xywav |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female asges 18 years and older with diagnosis of type 1 or type 2 narcolepsy. On an active prescription for Xyrem with stable treatment for at least 2 consecutive months.
Key inclusion criteria (9 listed)
- Male or female, aged 18 years or older
- Diagnosis of type 1 or type 2 narcolepsy by a physician
- Active prescription for Xyrem with a stable treatment regimen for at least 2 consecutive months
- Transitioning from Xyrem to Xywav within the next or past 7 days (- 7 days or + 7 days from the first dose of Xywav)
- Able to read and understand English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Transition from Xyrem to XywavThis is a single-group non-interventional study where participant's transitioning from Xyrem to Xywav will be observed. Investigational product (IP) or drug support or requested changes to their medication will not be provided to participants by Jazz Pharmaceuticals. The Xyrem and Xywav that the participants will take will be provided by the participant's health care provider. | Drug | Transition from Xyrem to Xywav |
Primary outcome
Number of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav
Time frame: Baseline to 21 Weeks
• Difference between usual Xyrem total nightly dose and initial prescribed total nightly Xywav dose.
2 secondary outcomes
Number Prescribed Dose Adjustments of Xywav
Time frame: Baseline to 21 Weeks
Duration of Time Between the Last Meal Relative to Dosing
Time frame: Baseline to 21 Weeks
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 30 Jun 2022.
- Individual participant dataSharing planned: No
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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.
1 site 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 Jazz Pharmaceuticals at 1 site 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 9 inclusion and 0 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav (time frame: Baseline to 21 Weeks). 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 30 Jun 2022.