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

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ClinicalTrials.gov Identifier: NCT05869773
Recruitment Status : Recruiting
First Posted : May 22, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Narcolepsy Drug: JZP258 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV
Actual Study Start Date : June 26, 2023
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arms and Interventions
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Arm Intervention/treatment
Experimental: JZP258
Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.
 Drug: JZP258
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution
Other Name: XYWAV


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from baseline to EOT Visit on the daytime average SBP in mmHg [ Time Frame: Baseline, Up to 6 weeks ]
  2. Change from baseline to EOT Visit on the seated resting average SBP in mmHg [ Time Frame: Baseline, Up to 6 weeks ]
  3. Change from baseline to EOT Visit on the nighttime average SBP in mmHg [ Time Frame: Baseline, Up to 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05869773


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

Locations
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Sponsors and Collaborators
Jazz Pharmaceuticals
More Information
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05869773    
Other Study ID Numbers: JZP258-406
First Posted: May 22, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jazz Pharmaceuticals:
Narcolepsy Type 1
Narcolepsy Type 2
XYWAV
JZP258
Oxybate
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders