NCT04803786

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	Transition from Xyrem to Xywav	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.

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-02-24
• Completion: 2022-02-24
• First posted: 2021-03-18
• Last updated: 2022-06-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study