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

Jazz Pharmaceuticals110 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

110

Conditions

Narcolepsy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female, aged 18 years or older 2. Diagnosis of type 1 or type 2 narcolepsy by a physician 3. Active prescription for Xyrem with a stable treatment regimen for at least 2 consecutive months 4. Transitioning from Xyrem to Xywav within the next or past 7 days (- 7 days or + 7 days from the first dose of Xywav) 5. Able to read and understand English 6. Able to access to a computer/smart phone with internet connection 7. Not currently a Jazz Pharmaceuticals employees or an immediate family member of a Jazz employee 8. Willing and able to comply with the study schedule 9. Willing and able to provide electronically written informed consent

Locations (1)

Jazz Pharmaceuticals Clinical Site

Palo Alto, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 21 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline to 21 Weeks

Data from ClinicalTrials.gov

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