Clinical trial NCT04803786: A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav
timeFrame: Baseline to 21 Weeks
Secondary outcomes:
measure: Number Prescribed Dose Adjustments of Xywav
timeFrame: Baseline to 21 Weeks
measure: Duration of Time Between the Last Meal Relative to Dosing
timeFrame: Baseline to 21 Weeks
Other outcomes:
measure: Time to Achieve Stable Dose of Xywav
timeFrame: Baseline to 21 Weeks
measure: Number of Participants Achieving Treatment Adherence
timeFrame: Baseline to 21 Weeks
measure: Number of Participants Who Discontinued Xywav Administration
timeFrame: Baseline to 21 Weeks
measure: Change in Short-term and Long-term Nausea Using Patient Global Impression of Change (PGI-C)
timeFrame: Baseline to 21 Weeks
measure: Changes in Sleep Pattern and Quality
timeFrame: Baseline to 21 Weeks
measure: Change in Epworth Sleepiness Scale (ESS)
timeFrame: Baseline to 21 Weeks
measure: Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score
timeFrame: Baseline to 21 Weeks
measure: Change in British Columbia Cognitive Complaint Inventory (BC-CCI) Total Score
timeFrame: Baseline to 21 Weeks
measure: Change in Cataplexy using PGI-c
timeFrame: Baseline to 21 Weeks
Locations:
city: Palo Alto
country: United States
facility: Jazz Pharmaceuticals Clinical Site
state: California
Study officials:
References: