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Narcolepsy patients may see blood pressure benefits by switching to Low-Sodium oxybate

NCT ID NCT05869773

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involved 155 adults with narcolepsy who were already taking a high-sodium oxybate medication. They switched to Xywav, a low-sodium version, to see if their blood pressure would improve. The goal was to provide doctors and patients with useful information about the impact of sodium content in narcolepsy treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xywav (low-sodium oxybate)
What this could lead to
If successful, this study could show that switching to a low-sodium oxybate lowers blood pressure, offering a safer option for managing narcolepsy.
What could go wrong
This is a small, completed Phase 4 study with no placebo group, so results may not apply to everyone. Blood pressure changes may vary and not be clinically significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

155 people

The number who actually took part.

Started

Jun 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

narcolepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Narcolepsy

Contacts and locations

Locations

  • Abington Neurological Associates, LTD

    Abington, Pennsylvania, 19001, United States

  • Advanced Respiratory and Sleep Medicine, PLLC

    Huntersville, North Carolina, 28078, United States

  • Antwerp University Hospital (UZA)

    Edegem, 2650, Belgium

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, 00133, Italy

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201, United States

  • Bryan Medical Center

    Lincoln, Nebraska, 68506, United States

  • CHU Nantes - Hôtel Dieu

    Nantes, Loire Atlantique, 44093, France

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, Isere, 38043, France

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • FWD Clinical Research

    Boca Raton, Florida, 33486, United States

  • Florida Pediatric Research Institute, LLC

    Orlando, Florida, 32804, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Henderson Clinical Trials LLC

    Henderson, Nevada, 89052, United States

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295, France

  • Hospital General de Castellon

    Castellon, 12004, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Araba - Sede Santiago

    Vitoria-Gasteiz, Alava, 01004, Spain

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040, Spain

  • IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)

    Bologna, 40139, Italy

  • Intrepid Research, LLC

    Cincinnati, Ohio, 45245, United States

  • Long Beach Research Institute

    Lakewood, California, 90805, United States

  • M3 Wake Research

    Encino, California, 91436, United States

  • Meris Clinical Research, LLC

    Brandon, Florida, 33511, United States

  • Neurocare, Inc

    Newton, Massachusetts, 02459, United States

  • OHSU Hospital

    Portland, Oregon, 97239, United States

  • Ocean Wellness Center

    Miami, Florida, 33169, United States

  • Ohio Sleep Medicine and Neuroscience

    Dublin, Ohio, 43017, United States

  • Ospedale San Raffaele (San Raffaele Turro)

    Milan, 20127, Italy

  • Private Practice RESPISOM Namur

    Namur, 5101, Belgium

  • SDS Clinical Trials, Inc.

    Santa Ana, California, 92705, United States

  • Saltzer Medical Group

    Nampa, Idaho, 83686, United States

  • Science 37

    Culver City, California, 90230, United States

  • Serenity Research Center LLC

    Miami, Florida, 33176, United States

  • Sleep Practitioners, LLC

    Macon, Georgia, 31210, United States

  • Sleep Therapy & Research Center

    San Antonio, Texas, 78229, United States

  • So Cal Clinical Research

    Huntington Beach, California, 92647, United States

  • Sparrow Health System

    Lansing, Michigan, 48911, United States

  • Stanford School of Medicine

    Redwood City, California, 94063, United States

  • TriValley Sleep Center

    San Ramon, California, 94583, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • Velocity Clinical Research, Greenville

    Greenville, South Carolina, 29615, United States

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