Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post approval study to investigate the efficacy of daridorexant in subjects with insomnia and comorbid nocturia

This study is looking into a medicine called daridorexant (also known as QUVIVIQ) for adults who struggle with sleep (insomnia) and also have to wake up frequently during the night to use the toilet (nocturia). Researchers want to find out how well this medicine helps people sleep for longer periods. They will compare it to a dummy pill (placebo) in a careful way, so neither the patients nor the doctors know who is getting the real medicine. The main goal is to see if daridorexant improves the total amount of sleep people get over four weeks. This type of study, called a Phase IV trial, usually happens after a medicine has already been approved, to gather more information about how it works in real-world situations.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd.

Enrolment target

Start

02 Mar 2023

Insomnia Disorder Nocturia

What is this study about?

This study is focusing on a new medicine called daridorexant, which you might know as QUVIVIQ. It's designed for people who have two common problems that often go hand-in-hand: difficulty sleeping (insomnia) and needing to get up multiple times during the night to pass urine (nocturia). Both of these can seriously affect your quality of life, making you tired during the day and impacting your overall health.

Researchers want to see if daridorexant can help people in this situation sleep better. Specifically, they're measuring if it increases the total amount of sleep people get during the night after four weeks of treatment. This is a "Phase IV" study, which means the medicine has already been approved for use, but doctors want to learn more about how it works in specific groups of people or for related conditions.

To make sure the results are fair and accurate, this study uses a method called "double-blind." This means that for a period, some participants will receive the actual medicine, and others will receive a dummy pill (a placebo) that looks exactly the same. Neither the participants nor the doctors will know who is getting what. Later, participants might switch over, so everyone gets a chance to try both the medicine and the dummy pill at different times. This careful approach helps doctors truly understand if the medicine is making a difference.

Key takeaways

Study examines daridorexant (QUVIVIQ) for sleep and night-time urination.
Aims to improve total sleep time for people with insomnia and nocturia.
Compares the medicine to a dummy pill to ensure fair results.
Open to adults aged 18 and over, both men and women.
Participation involves taking medication, clinic visits, and health monitoring.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults are also welcome to participate.

This study is open to both men and women.

The most important criteria are that you must be experiencing ongoing problems with both insomnia (trouble sleeping) and nocturia (waking up often to pee during the night). The study will have specific ways to check if your sleep and urination problems meet the study's 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.

Are you 18 years old or older?
Do you regularly struggle to sleep (insomnia)?
Do you often wake up at night to use the toilet (nocturia)?
Are you male or female?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would involve several visits to a clinic over a period. You would be given either the study medicine (daridorexant/QUVIVIQ) or a dummy pill (placebo) to take. You and the study doctors wouldn't know which one you're taking at any given time. After a period, you might switch to the other treatment. Throughout the study, you'd complete questionnaires about your sleep and urinary habits, and doctors would monitor your health. There will be initial assessments, regular check-ups, and a final follow-up. The total duration of your participation in the study would be outlined by the research team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit: the study medicine could improve your sleep and reduce how often you wake up to pee at night. However, there's also a chance you might receive a dummy pill, which won't directly treat your conditions. Like all medicines, daridorexant can have side effects, and the research team will explain these to you fully. Your safety is a top priority, and you'll be carefully monitored throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Germany

Common questions

What is insomnia?

Insomnia is when you regularly have trouble falling asleep, staying asleep, or getting good quality sleep, leaving you feeling tired during the day.

What is nocturia?

Nocturia is a medical term for needing to wake up two or more times during the night because you need to urinate.

What is a 'dummy pill' or 'placebo'?

A dummy pill (placebo) looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the real medicine?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know if you're taking the active medicine or the dummy pill at that time.

Why is this study being done if the medicine is already approved?

This 'Phase IV' study helps doctors learn more about how the medicine works in specific situations, like when insomnia is combined with nocturia, after it's generally available.