A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Narcolepsy

Intervention / Treatment
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* Drug: Transition from Xyrem to Xywav


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transition from Xyrem to Xywav<br> | Drug: Transition from Xyrem to Xywav<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 21 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to 21 Weeks |