Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography, dosefinding study assessing the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder
This research study is investigating a new medication called daridorexant, also known as QUVIVIQ, for children and teenagers aged 10 to 17 who experience insomnia, which is difficulty falling or staying asleep. The study is trying to find the best dose of this medicine to help them sleep better. To do this, some participants will receive daridorexant, while others will receive a dummy pill (placebo). Doctors will carefully measure sleep using special equipment in a sleep lab over a few nights to see if the medicine improves sleep. They will also check for any side effects and how the body handles the medicine. This is an early-stage study to understand if this treatment could be helpful for young people with insomnia.
At a glance
What is this study about?
This study is carefully looking into a new tablet called daridorexant (you might also hear it called QUVIVIQ). It's designed for young people aged 10 to 17 who have a medical condition called insomnia. Insomnia means regularly having trouble falling asleep, staying asleep, or getting good quality sleep, which can make you feel tired during the day. The main goal of this study is to find out if this new medicine can help these young people sleep better and if it's safe for them to take.
To make sure the results are fair and accurate, the study is set up in a very specific way. Some young people will get the active medicine, daridorexant, in different strengths (either 25 mg or 50 mg). Others will get a 'dummy' tablet, called a placebo, which looks exactly like the real medicine but contains no active drug. This is so researchers can compare how well the real medicine works against not taking any active medicine at all.
Researchers will use special sleep tests called polysomnography (often shortened to PSG) to measure sleep very accurately. These tests involve staying overnight in a sleep lab where sensors are placed on the body to record brain waves, breathing, and other body signals during sleep. They want to see if the medicine helps young people sleep more minutes each night, especially during the first day of treatment, compared to how they slept before starting the medicine. They will also look closely at any unexpected effects the medicine might have on the body.
Key takeaways
- This study is for young people aged 10-17 with insomnia.
- It's testing a new sleep medicine called daridorexant (QUVIVIQ).
- The aim is to find the best dose and check its safety and effectiveness.
- Participation involves overnight stays in a sleep lab to measure sleep.
- Some participants will get the actual medicine, others a dummy pill.
- Your involvement helps improve understanding of insomnia treatments for young people.
Who may be eligible?
This study is open to both boys and girls who are between 10 and 17 years old and have been diagnosed with insomnia, meaning they regularly struggle with their sleep.
Before you can join, doctors will need to do some health checks to make sure the study is a good fit for you. This is to ensure your safety and that the study results are reliable.
There might be some reasons why someone can't join, even if they have insomnia. For example, if you have other serious health conditions or are taking certain medications, the study might not be suitable. The doctors and study team will discuss all of these details with you and your parents.
- Are you between 10 and 17 years old?
- Have you been diagnosed with insomnia (regular trouble sleeping)?
- Are you generally healthy, apart from your insomnia?
- Are you able to visit a study clinic and stay overnight for sleep tests?
- Are you or your parents comfortable with you taking a study medication or a dummy pill?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would need to visit a special sleep clinic a few times. Initially, you'll have a couple of overnight stays in the sleep lab before you start any treatment. During these stays, doctors will use special equipment, called polysomnography, to record your sleep patterns to understand how you sleep normally. This helps them get a baseline measure before any medicine is given.
After these initial sleep recordings, you would begin taking either the study medicine (daridorexant) or the dummy pill (placebo) once a day, usually at night. You would then have another overnight stay in the sleep lab on the first day you take the medicine, so researchers can see how it affects your sleep immediately. Your health and any possible side effects would be carefully monitored throughout the study. The total time you would be involved in the main part of the study is quite short, focusing on specific nights of sleep measurement.
Potential risks and benefits
Locations (4)
- —Germany
- —Bulgaria
- —Spain
- —Italy
Common questions
What is insomnia?
Insomnia is when you regularly have trouble falling asleep, staying asleep, or getting good quality sleep, making you feel tired during the day.
What is daridorexant (QUVIVIQ)?
It's a new medicine being studied to help people with insomnia sleep better. It's not yet approved for children and teenagers.
What is a 'dummy pill' or placebo?
It looks exactly like the real medicine but contains no active drug. It helps researchers compare the real medicine's effects.
What is polysomnography (PSG)?
It's a special sleep test done in a sleep lab where sensors record your brain waves, breathing, and other body signals while you sleep.
Will I definitely get the active medicine?
No, because it's a 'double-blind' study, neither you nor the doctors will know if you're getting the active medicine or the dummy pill until after the study ends.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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