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

NCT04803786 | Completed FDA Drug

• 1 other identifier: JZP258-402
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 21 Weeks

Secondary Outcomes (2)

• Number Prescribed Dose Adjustments of Xywav

  Baseline to 21 Weeks

• Duration of Time Between the Last Meal Relative to Dosing

  Baseline to 21 Weeks

Other Outcomes (9)

• Time to Achieve Stable Dose of Xywav

  Baseline to 21 Weeks

• Number of Participants Achieving Treatment Adherence

  Baseline to 21 Weeks

• Number of Participants Who Discontinued Xywav Administration

  Baseline to 21 Weeks

Study Arms (1)

Transition from Xyrem to Xywav

Drug: Transition from Xyrem to Xywav

Interventions

Transition from Xyrem to Xywav DRUG

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.

Transition from Xyrem to Xywav

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Jazz Pharmaceuticals Clinical Site

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 18, 2021
• Study Start: April 9, 2021
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)