Not yet recruitingPHASE2INTERVENTIONAL

Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.

This study aims to find out if a new medicine called Solriamfetol can help people with Idiopathic Hypersomnia (IH) feel less sleepy and more awake. Idiopathic Hypersomnia is a condition that makes people feel extremely tired during the day, even after a full night's sleep. The study will involve giving some participants Solriamfetol and others a dummy pill (placebo) to see which is more effective. Participants won't know if they are getting the medicine or the dummy pill. The researchers will also carefully check for any side effects to make sure the medicine is safe. The goal is to see if this medicine could be a useful new treatment option for people living with IH.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University Hospital, Montpellier

Enrolment target

Start

15 Sep 2024

Estimated completion

01 Jun 2027

Idiopathic Hypersomnia

What is this study about?

This study is looking into a new medicine called Solriamfetol, which aims to help people who have a condition called Idiopathic Hypersomnia (IH). IH is a long-term sleep disorder where people feel very, very sleepy during the day, even if they've had plenty of sleep at night. This extreme tiredness can make everyday life really difficult.

The main point of this research is to see if Solriamfetol can actually make people with IH feel more awake and less sleepy. Researchers also want to make sure the medicine is safe and doesn't cause too many unwanted side effects. To do this fairly, some people in the study will get the actual medicine, and others will get a 'dummy pill' called a placebo, which looks just like the real medicine but has no active ingredients. This way, researchers can compare the effects of the medicine against not taking anything specific for IH.

This is a 'Phase II' study, which means it's an important early step in testing a new medicine. It's designed to give us more information about how well Solriamfetol works and what doses might be best. Finding new and effective treatments for IH could make a big difference to people living with this challenging condition.

Key takeaways

Tests a new medicine (Solriamfetol) for daytime sleepiness in Idiopathic Hypersomnia (IH).
Compares Solriamfetol to a dummy pill (placebo) to see if it works and is safe.
Participation involves taking a pill daily for about seven weeks.
Regular health checks and monitoring for side effects will occur.
This is an early-stage study to gather more information about the medicine.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be between 18 and 60 years old and have been diagnosed with Idiopathic Hypersomnia (IH) in the last five years. Your diagnosis must have been confirmed by sleep tests like a Polysomnography (PSG) and a Multiple Sleep Latency Test (MSLT), showing specific patterns of sleepiness or very long sleep times. It's also important that your sleep tests didn't show other major sleep problems like severe sleep apnoea or restless legs that wake you up.

You should also generally be in good health, with a healthy weight for your height. You'll need to be able to understand and speak French well. Certain health conditions or medications would mean you can't take part. For example, if you have unstable high blood pressure, certain other serious mental health conditions, a history of psychotic episodes, or other specific brain conditions, you wouldn't be able to join. You can't be taking certain stimulant medicines or other strong sedatives either, so it’s key to discuss all your current medicines with the study team.

The study also has rules about preventing pregnancy, so if you are able to get pregnant, you'll need to agree to use specific contraception methods that will be explained to you.

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 between 18 and 60 years old?
Have you been diagnosed with Idiopathic Hypersomnia (IH) in the last 5 years, confirmed by sleep tests?
Do you generally have good health and a healthy weight?
Are you able to understand and speak French well?
Are you currently not taking certain stimulant or sedative medicines?
Are you willing to discuss and follow contraceptive requirements if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to either receive the study medicine, Solriamfetol, or a dummy pill (placebo). You won't know which one you're getting, and neither will the study team. You'll take your assigned pill every morning when you wake up, for a period of about seven weeks.

During this time, you'll have several visits to the study clinic. These visits will involve blood tests, physical examinations, and possibly some questionnaires to check how you're feeling and if your sleepiness is changing. The doctors will also carefully monitor you for any side effects from the medicine. The total duration of your active participation in the study will be around seven weeks, followed by any necessary follow-up checks.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. You might benefit if you receive Solriamfetol and it helps to reduce your daytime sleepiness and improve your quality of life. Even if you receive the placebo, your condition will be closely monitored by medical professionals. Potential risks include experiencing side effects from Solriamfetol, which will be carefully explained to you by the study team. As with all studies, there's also the chance the treatment might not work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital of Montpellier
Verified postcode
Montpellier, France

Common questions

What is Idiopathic Hypersomnia (IH)?

IH is a long-term sleep disorder that causes people to feel excessively sleepy during the day, even after getting a full night's sleep.

What is a 'dummy pill' (placebo)?

A placebo looks like the actual medicine but doesn't contain any active ingredients. It's used in studies to fairly compare the effects of the real medicine.

Will I know if I'm getting the real medicine or the dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting which during the study.

How long will I be involved in the study?

Your active participation, taking the medicine or dummy pill, will last for about seven weeks.

What does a 'Phase II' study mean?

Phase II means this is an early stage of testing where researchers are looking more closely at how well the medicine works and if it's safe for people with IH.

How to find out more

Yves DAUVILLIERS, MD

y-dauvilliers@chu-montpellier.fr +33467335219 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.