#1 Clinical Trials Search in Europe

Calcium Oxybate

This article discusses a clinical trial investigating the effects of switching narcolepsy patients from high-sodium oxybate to XYWAV (calcium oxybate mixed-salt formulation) on blood pressure. The study aims to assess changes in systolic blood pressure over 24 hours, during daytime and nighttime, as well as seated resting blood pressure in participants with narcolepsy.

Table of Contents

What is XYWAV?

XYWAV is a new medication developed for the treatment of 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[1]. This medication is designed to be a lower-sodium alternative to high-sodium oxybate treatments that have been previously used for narcolepsy.

How XYWAV Works

XYWAV is an oral solution that works by affecting certain neurotransmitters in the brain[1]. The oxybate compounds in XYWAV are believed to help regulate sleep patterns and reduce the symptoms of narcolepsy. By using a mixture of different oxybate salts, XYWAV aims to provide the therapeutic benefits of oxybate while reducing the sodium content compared to traditional high-sodium oxybate medications.

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[1]. The medication is designed for patients with either Type 1 or Type 2 narcolepsy. Type 1 narcolepsy involves sudden loss of muscle tone (cataplexy), while Type 2 does not include cataplexy.

Dosage and Administration

XYWAV is administered as an oral solution, typically taken twice nightly[1]. The maximum daily dose is 9 grams, and the treatment period can last up to 6 weeks[1]. It’s important to note that the exact dosage and duration of treatment should be determined by a healthcare professional based on individual patient needs and response to the medication.

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
  • Documented diagnosis of Type 1 or Type 2 narcolepsy
  • Previous treatment with high-sodium oxybate for at least 6 consecutive weeks
  • Systolic blood pressure between 130 and 155 mm Hg
  • Diastolic blood pressure not greater than 95 mm Hg

Patients with certain medical conditions or taking specific medications may not be eligible for XYWAV treatment. It’s crucial to discuss your complete medical history with your healthcare provider.

Potential Benefits of XYWAV

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

Precautions and Contraindications

XYWAV may not be suitable for everyone. Some conditions that may prevent the use of XYWAV include[1]:

  • Severe kidney impairment
  • Unstable medical conditions or psychiatric disorders
  • Significant cardiovascular disease
  • History of substance use disorders
  • Phenylketonuria or hypersensitivity to phenylalanine-derived products
  • Succinic semi-aldehyde dehydrogenase deficiency

It’s essential to provide your doctor with a complete medical history and list of all medications you’re taking to ensure XYWAV is safe and appropriate for you.

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 SBP
Secondary Objectives Assess changes in daytime, seated resting, and nighttime SBP
Participant Age 18 to 70 years
Inclusion Criteria Narcolepsy diagnosis, current use of high-sodium oxybate, specific SBP range
Exclusion Criteria Unstable medical conditions, renal impairment, resistant hypertension, significant cardiovascular disease
Primary Endpoint Change in 24-hour average SBP from baseline to end of treatment
Study 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 an average systolic blood pressure between 130 and 155 mm Hg.
  • What is XYWAV? XYWAV is a mixed-salt formulation of oxybate that contains calcium, magnesium, potassium, and sodium oxybate. It is being studied as an alternative to high-sodium oxybate for treating narcolepsy.
  • 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 measurements taken during the study? The main measurements include 24-hour ambulatory systolic blood pressure, daytime and nighttime blood pressure, and seated resting blood pressure. These will be compared from the beginning to the end of the study to evaluate the effects of switching to XYWAV.

Ongoing Clinical Trials on Calcium 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 excessive daytime sleepiness, sudden loss of muscle tone (cataplexy), and disrupted nighttime sleep.
  • Systolic Blood Pressure (SBP): The pressure in your arteries when your heart beats, typically the higher number in a blood pressure reading.
  • Ambulatory Blood Pressure: Blood pressure measurements taken at regular intervals throughout the day and night, usually with a portable device worn by the patient.
  • XYWAV: A mixed-salt formulation of oxybate containing calcium, magnesium, potassium, and sodium oxybate, used to treat narcolepsy.
  • High-Sodium Oxybate: A medication used to treat narcolepsy that contains a high amount of sodium, such as XYREM.
  • Diastolic Blood Pressure (DBP): The pressure in your arteries when your heart is at rest between beats, typically the lower number in a blood pressure reading.
  • ICSD-3: International Classification of Sleep Disorders, 3rd edition, a diagnostic manual for sleep disorders.
  • DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th edition, used for diagnosing mental health conditions.
  • Creatinine Clearance: A test that measures how well your kidneys are working by estimating how much blood passes through the glomeruli each minute.
  • Resistant Hypertension: High blood pressure that remains above goal levels despite the use of three antihypertensive medications of different classes at optimal doses, one of which should be a diuretic.

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/