A randomized, double-blind, placebo-controlled trial comparing the efficacy and tolerance of solriamfetol in patients affected with idiopathic hypersomnia. SOLR-IH
This research study is looking into a new medicine called solriamfetol. It's for adults who have idiopathic hypersomnia, which is a problem where you feel extremely sleepy during the day, even after a full night's sleep, and doctors can't find another clear reason for it. The study aims to find out if this new medicine can help people feel less sleepy and function better in their daily lives. To do this, some people will get the new medicine, and others will get a placebo (a dummy pill with no active medicine), to see if there's a real difference. Researchers will also check to make sure the medicine is safe and doesn't cause too many side effects.
At a glance
What is this study about?
This study is about a condition called idiopathic hypersomnia. If you have this, you feel very, very sleepy during the day, even if you've slept well at night. It's not the same as just feeling tired; it's a deep urge to sleep that can make it hard to do everyday things.
The researchers are testing a new medicine called solriamfetol to see if it can help people with idiopathic hypersomnia feel more awake and less sleepy. They want to find out how well it works and if it's safe to use. This kind of study is called a "Phase II" trial, which means it's an early stage of testing a new medicine, usually after it's been shown to be safe in a small group of people, to see if it has a real effect on the condition.
To make sure the results are fair, some people in the study will get the real medicine, and others will get a placebo. A placebo looks just like the real medicine but has no active ingredients. Neither you nor your doctor will know if you're getting the real medicine or the placebo – this is called "double-blind." This helps doctors see if the new medicine genuinely works better than nothing at all. They will carefully monitor everyone to see if they feel better and to check for any side effects.
Key takeaways
- This study is for adults with idiopathic hypersomnia.
- It's testing a new medicine called solriamfetol to reduce daytime sleepiness.
- Some people will get the real medicine; others will get a dummy pill (placebo).
- You'll have regular visits for check-ups and tests.
- The study aims to see if the medicine works and is safe.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. Both men and women are welcome to take part. The main thing is that you must have been diagnosed with idiopathic hypersomnia.
There might be some other health conditions or medicines that would prevent you from joining, as the researchers need to make sure the study is safe for everyone involved and that the results are clear. Your doctor or the study team will be able to explain all the specific requirements in detail.
Generally, if you're an adult living with idiopathic hypersomnia, you could be a candidate for this study. The research team will review your medical history to confirm if you meet all the criteria.
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?
- Have you been diagnosed with idiopathic hypersomnia?
- Are you generally able to attend regular clinic appointments?
- Are you willing to potentially receive either the study medicine or a placebo?
What does participation involve?
If you decide to take part in this study, you won't know if you're getting the new medicine or a dummy pill (placebo). You'll be asked to take the study medicine as instructed. You will also need to attend several appointments at the study clinic. During these visits, doctors and nurses will do different tests and ask you questions about how you're feeling and how sleepy you are. These might include questionnaires, physical check-ups, and possibly some sleep-related tests.
These visits are important for the researchers to track how well the medicine is working and to keep an eye on your health and any side effects. After you finish taking the medicine, there will be some follow-up appointments to ensure everything is well. The total time you'd be involved in the study would depend on the study plan, but the team will explain this fully before you decide to join.
Potential risks and benefits
Locations (1)
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Common questions
What is idiopathic hypersomnia (IH)?
It's a sleep disorder where you feel very sleepy during the day, even after a full night's sleep, and doctors can't find another clear reason for it.
What is solriamfetol?
It's a new medicine being tested to see if it helps people with idiopathic hypersomnia feel more awake and less sleepy.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare against the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know. This is called 'double-blind' and helps ensure the study results are fair.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your regular medical care.
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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