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

Completed

• Conditions: Narcolepsy
• Interventions: Drug: Transition from Xyrem to Xywav

• Registration Number: NCT04803786
• Lead Sponsor: Jazz Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-04-09
• Primary Completion: 2022-02-24
• Study Completion: 2022-02-24
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transition from Xyrem to Xywav	Transition from Xyrem to Xywav	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav	Baseline to 21 Weeks	• Difference between usual Xyrem total nightly dose and initial prescribed total nightly Xywav dose.

Secondary Outcome Measures

Name	Time	Method
Number Prescribed Dose Adjustments of Xywav	Baseline to 21 Weeks	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.
Duration of Time Between the Last Meal Relative to Dosing	Baseline to 21 Weeks	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.

Trial Locations

Locations (1)

Jazz Pharmaceuticals Clinical Site; 🇺🇸 Palo Alto, California, United States