A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

• ClinicalTrials.gov Identifier: NCT05869773
• Recruitment Status: Recruiting
• First Posted: May 22, 2023
• Last Update Posted: May 10, 2024
• Sponsor: Jazz Pharmaceuticals
• Information provided by (Responsible Party): Jazz Pharmaceuticals

Tracking Information

• First Submitted Date: May 12, 2023
• First Posted Date: May 22, 2023
• Last Update Posted Date: May 10, 2024
• Actual Study Start Date: June 26, 2023
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 12, 2023): Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg [ Time Frame: Baseline, Up to 6 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 12, 2023)

• Change from baseline to EOT Visit on the daytime average SBP in mmHg [ Time Frame: Baseline, Up to 6 weeks ]
• Change from baseline to EOT Visit on the seated resting average SBP in mmHg [ Time Frame: Baseline, Up to 6 weeks ]
• Change from baseline to EOT Visit on the nighttime average SBP in mmHg [ Time Frame: Baseline, Up to 6 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
• Official Title: An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV
• Brief Summary: The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Narcolepsy

Intervention

Drug: JZP258

0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution

Other Name: XYWAV

Study Arms

Experimental: JZP258

Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.

Intervention: Drug: JZP258

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 12, 2023): 89
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2025
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Participants must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
• Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meets International Classification of Sleep Disorders (ICSD)-3 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.
• Participants must have been receiving a dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) for a minimum of 6 consecutive weeks prior to screening.
• If currently treated with stimulants and/or alerting agents or other medications known to affect BP, participant must have been taking the same dosing regimen for at least 2 months prior to screening and agree to take the same dose throughout the study.
• If currently taking stable doses of antihypertensive therapies, participant must maintain these treatments at the same dose throughout the study unless otherwise advised by their medical care
• Participant is male or female. A female participant is eligible to participate if she is not pregnant or breastfeeding, if she is a woman of nonchildbearing potential or is a woman of childbearing potential and using a contraceptive method that is highly effective.

Key Exclusion Criteria:

• History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the participant or interfere with study assessments or the ability of the participant to complete the study based on the judgment of the investigator.
• Presence of significant cardiovascular disease.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trial Disclosure & Transparency; 215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

• Listed Location Countries: Belgium, Czechia, France, Italy, Spain, United States

Administrative Information

• NCT Number: NCT05869773
• Other Study ID Numbers: JZP258-406
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jazz Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Jazz Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jazz Pharmaceuticals
• Verification Date: May 2024