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NCT05869773 | COMPLETED | Narcolepsy

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

Jazz Pharmaceuticals

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

Narcolepsy

Intervention/treatment

JZP258

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
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 : 2023-06-26
Estimated Primary Completion Date : 2025-02-25
Estimated Study Completion Date : 2025-03-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 total dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing 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 or cardiovascular condition that in the investigator's opinion may jeopardize participant safety in the study, including screening ECG results.
    • * Presence of atrial fibrillation detected on screening electrocardiogram (ECG).
    • * Presence of resistant hypertension.
A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

Location Details

NCT05869773

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Science 37

Culver City, California, United States, 90230

Not yet recruiting

United States, California

M3 Wake Research

Encino, California, United States, 91436

Not yet recruiting

United States, California

So Cal Clinical Research

Huntington Beach, California, United States, 92647

Not yet recruiting

United States, California

Long Beach Research Institute

Lakewood, California, United States, 90805

Not yet recruiting

United States, California

Stanford School of Medicine

Redwood City, California, United States, 94063

Not yet recruiting

United States, California

TriValley Sleep Center

San Ramon, California, United States, 94583

Not yet recruiting

United States, California

SDS Clinical Trials, Inc.

Santa Anna, California, United States, 92705

Not yet recruiting

United States, Florida

FWD Clinical Research

Boca Raton, Florida, United States, 33486

Not yet recruiting

United States, Florida

Meris Clinical Research, LLC

Brandon, Florida, United States, 33511

Not yet recruiting

United States, Florida

Ocean Wellness Center

Miami, Florida, United States, 33169

Not yet recruiting

United States, Florida

Serenity Research Center LLC

Miami, Florida, United States, 33176

Not yet recruiting

United States, Florida

Florida Pediatric Research Institute, LLC

Orlando, Florida, United States, 32804

Not yet recruiting

United States, Georgia

Sleep Practitioners, LLC

Macon, Georgia, United States, 31210

Not yet recruiting

United States, Idaho

Saltzer Medical Group

Nampa, Idaho, United States, 83686

Not yet recruiting

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

Not yet recruiting

United States, Maryland

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Not yet recruiting

United States, Massachusetts

Neurocare, Inc

Newton, Massachusetts, United States, 02459

Not yet recruiting

United States, Road cancer

Sparrow Health System

Lansing, Road cancer, United States, 48911

Not yet recruiting

United States, Nebraska

Bryan Medical Center

Lincoln, Nebraska, United States, 68506

Not yet recruiting

United States, Nevada

Henderson Clinical Trials LLC

Henderson, Nevada, United States, 89052

Not yet recruiting

United States, North Carolina

Advanced Respiratory and Sleep Medicine, PLLC

Huntersville, North Carolina, United States, 28078

Not yet recruiting

United States, Ohio

Intrepid Research, LLC

Cincinnati, Ohio, United States, 45245

Not yet recruiting

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Not yet recruiting

United States, Ohio

Ohio Sleep Medicine and Neuroscience

Dublin, Ohio, United States, 43017

Not yet recruiting

United States, Oregon

OHSU Hospital

Portland, Oregon, United States, 97239

Not yet recruiting

United States, Pennsylvania

Abington Neurological Associates, LTD

Abington, Pennsylvania, United States, 19001

Not yet recruiting

United States, South Carolina

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States, 29201

Not yet recruiting

United States, South Carolina

Velocity Clinical Research, Greenville

Greenville, South Carolina, United States, 29615

Not yet recruiting

United States, South Carolina

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States, 29732

Not yet recruiting

United States, Texas

FutureSearch Trials of Neurology

Austin, Texas, United States, 78731

Not yet recruiting

United States, Texas

Sleep Therapy & Research Center

San Antonio, Texas, United States, 78229

Not yet recruiting

Belgium,

Antwerp University Hospital (UZA)

Edegem, Belgium, 2650

Not yet recruiting

Belgium,

Private Practice RESPISOM Namur

Namur, Belgium, 5101

Not yet recruiting

France, Herault

Chauliac guopital

Montpellier, Herault, France, 34295

Not yet recruiting

France, Generous

Grenoble University Hospital - Albert Michallon Hospital

Grenoble, The toys, France, 38043

Not yet recruiting

France, Loire Atlantique

Chu Nantes - Hôtel Dieu

Nantes, Loire Atlantique, France, 44093

Not yet recruiting

Italy,

IRCCS Institute of Neurological Sciences of Bologna (ISNB)

Bologna, Italy, 40139

Not yet recruiting

Italy,

San Raffaele Hospital (San Raffaele Turro)

Milano, Italy, 20127

Not yet recruiting

Italy,

Polyclinic University Hospital Tor Vergata

Roma, Italy, 00133

Not yet recruiting

Spain, Alva

Araba University Hospital - Santiago Headquarters

Vitoria, Alh, Spain, 01004

Not yet recruiting

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

Not yet recruiting

Spain,

Castellon General Hospital

Castellon, Spain, 12004

Not yet recruiting

Spain,

San Carlos Clinic University Hospital

Madrid, Spain, 28040