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

NCT04803786 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2022-06-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2022-02-24
Completion
2022-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803786 on ClinicalTrials.gov