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

Last updated: April 4, 2025
Sponsor: Jazz Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Narcolepsy

Treatment

JZP258

Clinical Study ID

NCT05869773
JZP258-406
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants must be 18 to 70 years of age inclusive, at the time of signing theinformed consent.

  • Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meetsInternational Classification of Sleep Disorders (ICSD)-3 or Diagnostic andStatistical Manual of Mental Disorders (DSM)-5 criteria.

  • Participants must have been receiving a total dose of high-sodium oxybate (eg,XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing for a minimum of 6consecutive weeks prior to screening.

  • If currently treated with stimulants and/or alerting agents or other medicationsknown to affect BP, participant must have been taking the same dosing regimen for atleast 2 months prior to screening and agree to take the same dose throughout thestudy.

  • If currently taking stable doses of antihypertensive therapies, participant mustmaintain these treatments at the same dose throughout the study unless otherwiseadvised by their medical care

  • Participant is male or female. A female participant is eligible to participate ifshe is not pregnant or breastfeeding, if she is a woman of nonchildbearing potentialor is a woman of childbearing potential and using a contraceptive method that ishighly effective.

Exclusion

Key Exclusion Criteria:

  • History or presence of any acutely unstable medical condition, behavioral orpsychiatric disorder (including active suicidal ideation), or surgical history thatcould affect the safety of the participant or interfere with study assessments orthe ability of the participant to complete the study based on the judgment of theinvestigator.

  • Presence of significant cardiovascular disease or cardiovascular condition that inthe investigator's opinion may jeopardize participant safety in the study, includingscreening ECG results.

  • Presence of atrial fibrillation detected on screening electrocardiogram (ECG).

  • Presence of resistant hypertension.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: JZP258
Phase: 4
Study Start date:
June 26, 2023
Estimated Completion Date:
March 10, 2025

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussel, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Site Not Available

  • Antwerp University Hospital (UZA)

    Edegem, 2650
    Belgium

    Site Not Available

  • Private Practice RESPISOM Namur

    Namur, 5101
    Belgium

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 128 21
    Czechia

    Site Not Available

  • Hopital Gui de Chauliac

    Montpellier, Herault 34295
    France

    Site Not Available

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, Isere 38043
    France

    Site Not Available

  • CHU Nantes - Hôtel Dieu

    Nantes, Loire Atlantique 44093
    France

    Site Not Available

  • Hopital Roger Salengro - CHU Lille

    Lille Cedex, Nord 59037
    France

    Site Not Available

  • IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)

    Bologna, 40139
    Italy

    Site Not Available

  • Ospedale San Raffaele (San Raffaele Turro)

    Milano, 20127
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • Hospital Universitario Araba - Sede Santiago

    Vitoria, Alava 01004
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital General de Castellon

    Castellon, 12004
    Spain

    Site Not Available

  • Hospital General de Castellon

    Castillón, 12004
    Spain

    Site Not Available

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85721
    United States

    Site Not Available

  • Science 37

    Culver City, California 90230
    United States

    Site Not Available

  • M3 Wake Research

    Encino, California 91436
    United States

    Site Not Available

  • M3 Wake Research, Inc.

    Encino, California 91436
    United States

    Active - Recruiting

  • So Cal Clinical Research

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Long Beach Research Institute

    Lakewood, California 90805
    United States

    Site Not Available

  • Stanford School of Medicine

    Redwood City, California 94063
    United States

    Site Not Available

  • Rady Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Sleep Medicine Specialists of California

    San Ramon, California 94583
    United States

    Site Not Available

  • TriValley Sleep Center

    San Ramon, California 94583
    United States

    Site Not Available

  • SDS Clinical Trials, Inc

    Santa Ana, California 92705
    United States

    Site Not Available

  • SDS Clinical Trials, Inc.

    Santa Ana, California 92705
    United States

    Site Not Available

  • FWD Clinical Research

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Meris Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Meris Clinical Research, LLC

    Brandon, Florida 33511
    United States

    Site Not Available

  • Nova Research Institute LLC

    Miami, Florida 33125
    United States

    Site Not Available

  • Ocean Wellness Center

    Miami, Florida 33169
    United States

    Site Not Available

  • Serenity Research Center LLC

    Miami, Florida 33176
    United States

    Site Not Available

  • Florida Pediatric Research Institute, LLC

    Orlando, Florida 32804
    United States

    Site Not Available

  • Sleep Practioners , LLC

    Macon, Georgia 31210
    United States

    Site Not Available

  • Sleep Practitioners, LLC

    Macon, Georgia 31210
    United States

    Site Not Available

  • Saltzer Medical Group

    Nampa, Idaho 83686
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Neurocare, Inc

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • Neurocare, Inc.

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

  • Sparrow Health System

    Lansing, Michigan 48911
    United States

    Site Not Available

  • Bryan Medical Center

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Henderson Clinical Trials LLC

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Henderson Clinical Trials, LLC

    Henderson, Nevada 89052
    United States

    Site Not Available

  • M3 Wake Research, Inc.

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Advanced Respiratory and Sleep Medicine, LLC

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Advanced Respiratory and Sleep Medicine, PLLC

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Intrepid Research, LLC

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • Metro Health Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio Sleep Medicine and Neuroscience

    Dublin, Ohio 43017
    United States

    Site Not Available

  • OHSU Hospital

    Portland, Oregon 97239
    United States

    Site Not Available

  • Abington Neurological Associates, LTD

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Velocity Clinical Research, Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • Sleep Therapy & Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Sleep Therapy and Research Center

    San Antonio, Texas 78229
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.