Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV

This research study is for people who have narcolepsy and are currently taking a specific type of narcolepsy medicine called high-sodium oxybate. The main goal is to understand if switching to a newer medicine called JZP258 (also known as XYWAV) can lead to changes in blood pressure. Researchers will measure blood pressure over a full 24-hour period to see if there's any difference after switching medicines. They will also look at blood pressure during the day, at night, and while sitting down. Participants will be aged 18 or older. This is a Phase III study, which means it's one of the final steps before a medicine might be approved for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Jazz Pharmaceuticals PLC

Enrolment target

Start

14 Nov 2023

Narcolepsy

What is this study about?

Narcolepsy is a long-term condition that seriously affects the brain's ability to regulate sleep and wakefulness. People with narcolepsy can feel very sleepy during the day, even after getting enough sleep at night. They might also have sudden, uncontrollable urges to sleep, or even lose muscle control in upsetting or exciting situations. Some medicines used to treat narcolepsy can affect blood pressure, and managing blood pressure is important for overall health.

This study wants to find out if a newer medicine, JZP258 (also known as XYWAV), could be a good choice for people with narcolepsy who are currently taking a similar medicine that contains a higher amount of sodium, which can sometimes raise blood pressure. The study will carefully measure participants' blood pressure changes after they switch from their current narcolepsy medicine to JZP258. The main focus is on how blood pressure changes over a full day.

The information gathered from this study is very important because it will help doctors and patients understand how JZP258 affects blood pressure compared to other treatments. This could help make decisions about which medicine is best for individual patients with narcolepsy, especially those who might be concerned about their blood pressure.

Key takeaways

This study is for adults with narcolepsy.
It investigates how a new narcolepsy medicine, XYWAV, affects blood pressure.
Participants will switch from high-sodium oxybate to XYWAV.
Blood pressure will be carefully monitored over 24 hours.
The goal is to understand if XYWAV is a good option for managing narcolepsy and blood pressure.

Who may be eligible?

This study is looking for adults who have narcolepsy. You need to be at least 18 years old to take part.

Crucially, you must already be taking a specific type of narcolepsy medicine called high-sodium oxybate. This study aims to see what happens when you switch from that medicine to the new study medicine.

Both men and women are welcome to participate in the study, as long as they meet the other requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have narcolepsy?
Are you 18 years old or older?
Are you currently taking a medicine called high-sodium oxybate for your narcolepsy?

Answer every question to see your result.

What does participation involve?

If you join this study, it would involve switching from your current narcolepsy medicine to the new study medicine, JZP258 (XYWAV). You would have several visits to the study clinic where the research team would closely monitor your health.

During these visits, they would perform various health checks, with a strong focus on taking your blood pressure measurements. This includes wearing a special device that measures your blood pressure continuously over 24 hours. The study team will explain all the procedures in detail and tell you how long the study will last for you. There will also be regular follow-up appointments to ensure your well-being throughout the study.

Potential risks and benefits

Participating in this study might offer a potential benefit of switching to a new narcolepsy medicine that could have a different effect on your blood pressure. However, like all medicines, JZP258 (XYWAV) can have side effects, and switching medicines always carries a risk of new or different side effects. The study team will monitor you closely for any changes in your health. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia
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Unverified
France
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Unverified
Belgium
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Unverified
Italy
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Unverified
Spain

Common questions

What is narcolepsy?

Narcolepsy is a condition that makes it hard for your brain to control when you're awake and asleep, leading to extreme tiredness and sudden sleep attacks.

What is JZP258 (XYWAV)?

JZP258, also known as XYWAV, is a medicine for treating narcolepsy. This study is looking at how it affects blood pressure compared to another similar medicine.

Why are they looking at blood pressure?

Some narcolepsy medicines can affect blood pressure. This study wants to see if JZP258 (XYWAV) helps manage blood pressure better for people who switch from a different medicine.

Will I have to stop my current narcolepsy medicine immediately?

The study involves switching from your current high-sodium oxybate medicine to JZP258 (XYWAV). The study team will guide you through this process carefully.

Is this medicine already available?

This is a 'Phase III' study, which means it's one of the last stages of testing before a medicine might be widely approved for use.