#1 Clinical Trials Search in Europe

Magnesium Oxybate

This article discusses a clinical trial investigating the effects of switching narcolepsy patients from high-sodium oxybate to XYWAV, a drug containing magnesium oxybate and other oxybate salts. The study aims to evaluate changes in blood pressure and other related factors in participants with narcolepsy who make this switch.

Table of Contents

What is XYWAV?

XYWAV is a new medication designed to treat narcolepsy. It is also known as JZP258 or Oxybate Mixed-Salt Formulation[1]. XYWAV contains a combination of four active substances: sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate. This formulation is different from the previously used high-sodium oxybate medications, as it aims to reduce the sodium content while maintaining effectiveness[1].

How XYWAV Works

XYWAV works by affecting the central nervous system to help regulate sleep patterns in people with narcolepsy. The oxybate compounds in XYWAV act on specific receptors in the brain to improve nighttime sleep and reduce daytime sleepiness. By using a mix of different oxybate salts, XYWAV provides the therapeutic benefits of oxybate while reducing the overall sodium intake[1].

Conditions Treated by XYWAV

XYWAV is primarily used to treat narcolepsy, a chronic sleep disorder characterized by excessive daytime sleepiness and sudden attacks of sleep. It can be used for both Type 1 and Type 2 narcolepsy[1].

  • Type 1 Narcolepsy: This form of narcolepsy is associated with sudden loss of muscle tone (cataplexy) and is caused by a lack of hypocretin in the brain.
  • Type 2 Narcolepsy: This type does not involve cataplexy but still causes excessive daytime sleepiness.

Dosage and Administration

XYWAV is an oral solution taken twice nightly. The maximum daily dose is 9 grams, divided into two doses[1]. The exact dosage may vary depending on the individual patient’s needs and response to treatment. It’s important to follow the prescribing doctor’s instructions carefully when taking XYWAV.

Eligibility Criteria for XYWAV Treatment

To be eligible for XYWAV treatment, patients typically need to meet certain criteria[1]:

  • Age between 18 and 70 years
  • Diagnosed with Type 1 or Type 2 narcolepsy according to ICSD-3 or DSM-5 criteria
  • Previously treated with high-sodium oxybate at a dose of 6 to 9 g/night for at least 6 weeks
  • If taking other medications that affect blood pressure, the dosage should be stable for at least 2 months
  • Systolic blood pressure between 130 and 155 mm Hg
  • Diastolic blood pressure not greater than 95 mm Hg

Potential Benefits of XYWAV

The main potential benefit of XYWAV is its lower sodium content compared to previous oxybate treatments. This is particularly important for patients with narcolepsy who may be at risk of high blood pressure. A clinical study is being conducted to evaluate the impact of switching from high-sodium oxybate to XYWAV on blood pressure in narcolepsy patients[1]. The study aims to measure changes in:

  • 24-hour average systolic blood pressure
  • Daytime average systolic blood pressure
  • Seated resting average systolic blood pressure
  • Nighttime average systolic blood pressure
These measurements will help determine if XYWAV can effectively treat narcolepsy while potentially reducing the risk of high blood pressure associated with high-sodium treatments.

Precautions and Contraindications

XYWAV may not be suitable for everyone. Some conditions that may prevent a person from using XYWAV include[1]:

  • Unstable medical conditions or psychiatric disorders
  • Renal impairment with creatinine clearance less than 45 mL/min
  • Resistant hypertension (high blood pressure that’s difficult to control)
  • Significant cardiovascular disease
  • Atrial fibrillation
  • Recent or current substance use disorders
  • History of phenylketonuria or hypersensitivity to phenylalanine-derived products
  • Succinic semi-aldehyde dehydrogenase deficiency
It’s crucial to discuss your full medical history with your doctor before starting XYWAV treatment.

Aspect Details
Study Type Open-label, multicenter switch study
Main Objective Evaluate impact of switching from high-sodium oxybate to XYWAV on 24-hour ambulatory systolic blood pressure
Participants Adults (18-70 years) with narcolepsy Type 1 or 2
Key Inclusion Criteria Taking high-sodium oxybate 6-9 g/night for at least 6 weeks; specific blood pressure readings
Key Exclusion Criteria Unstable medical conditions, renal impairment, resistant hypertension, significant cardiovascular disease
Primary Endpoint Change in 24-hour average systolic blood pressure from baseline to end of treatment
Secondary Endpoints Changes in daytime, seated resting, and nighttime average systolic blood pressure
Study Drug XYWAV (containing sodium, calcium, magnesium, and potassium oxybate)
Maximum Daily Dose 9 grams
Treatment Duration Up to 6 weeks

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to evaluate how switching from high-sodium oxybate to XYWAV affects 24-hour ambulatory systolic blood pressure in people with narcolepsy.
  • Who can participate in this study? Participants must be 18 to 70 years old, have a diagnosis of Type 1 or Type 2 narcolepsy, and have been taking high-sodium oxybate at a specific dose for at least 6 weeks before screening. They must also have certain blood pressure readings and meet other specific criteria.
  • What is XYWAV? XYWAV is a drug containing a mixture of oxybate salts, including sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate. It is being studied as an alternative to high-sodium oxybate for narcolepsy treatment.
  • How long does the study last? The study lasts up to 6 weeks, during which participants will switch from their current high-sodium oxybate medication to XYWAV.
  • What are the main things the researchers will measure? The researchers will primarily measure changes in 24-hour average systolic blood pressure. They will also look at daytime average blood pressure, seated resting blood pressure, and nighttime average blood pressure.

Ongoing Clinical Trials on Magnesium Oxybate

  • Study on Blood Pressure Changes in Narcolepsy Patients Switching from High-Sodium Oxybate to JZP258 (Oxybate Mixed-Salt Formulation)

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Italy Spain

Glossary

  • Narcolepsy: A chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep.
  • Systolic Blood Pressure (SBP): The pressure in your arteries when your heart beats and pumps blood out.
  • Diastolic Blood Pressure (DBP): The pressure in your arteries when your heart is at rest between beats.
  • Ambulatory Blood Pressure: Blood pressure measurements taken at regular intervals throughout the day and night, usually with a portable device.
  • XYWAV: A medication containing a mixture of oxybate salts, including magnesium oxybate, used to treat narcolepsy.
  • Oxybate: A salt or ester of gamma-hydroxybutyric acid (GHB), used in medications to treat narcolepsy.
  • ICSD-3: International Classification of Sleep Disorders, 3rd edition – a guide for diagnosing sleep disorders.
  • DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th edition – a guide for diagnosing mental health conditions.
  • WOCBP: Woman of Childbearing Potential – a term used in clinical trials to describe women who can become pregnant.
  • Creatinine Clearance: A test that measures how well your kidneys are working by estimating how much blood the kidneys can filter in a minute.

References

  1. http://clinicaltrials.eu/trial/study-on-blood-pressure-changes-in-narcolepsy-patients-switching-from-high-sodium-oxybate-to-jzp258-oxybate-mixed-salt-formulation/