An open-label sleep laboratory study of efficacy and safety of piromelatine in a well-defined population of patients with idiopathic (isolated) Rapid Eye Movement Behavior Disorder (iRBD).
This study is looking into a new medication called piromelatine for adults who have a specific sleep condition known as isolated Rapid Eye Movement (REM) Behavior Disorder (iRBD). People with iRBD act out vivid dreams during sleep, leading to potentially harmful movements or shouting. The main aim of this research is to see how well piromelatine works to lessen these dream-enacting behaviours and to make sure it's safe for participants. Researchers will be observing sleep patterns and overall health closely in a special sleep lab to understand the effects of the medicine.
At a glance
What is this study about?
This research is focused on a sleep condition called isolated Rapid Eye Movement (REM) Behavior Disorder, often shortened to iRBD. Normally, when you're dreaming during REM sleep, your body is temporarily paralysed, which stops you from acting out your dreams. However, people with iRBD don't have this paralysis, so they might punch, kick, shout, or even jump out of bed while dreaming. This can be disruptive and sometimes dangerous for them or their bed partner.
Researchers are testing a new medication called piromelatine (also known as Neu-P11) in people with iRBD. This is an early-stage study, meaning it's one of the first times this medicine is being tested in a group of patients. The main goal is to find out if piromelatine can safely reduce the number and severity of these dream-enacting behaviours during sleep. They’ll also be looking at how it affects overall sleep quality.
Scientists will be carefully monitoring participants in a sleep lab. This involves using special equipment to record brain activity, eye movements, and muscle movements during sleep. They'll also ask participants about their sleep quality and daytime tiredness. This detailed information will help them understand if piromelatine is a promising treatment for iRBD, potentially improving sleep and reducing the risks associated with the condition.
Key takeaways
- The study tests new medicine, piromelatine, for a sleep disorder called iRBD.
- iRBD causes people to act out dreams during sleep.
- Researchers will check if piromelatine is safe and reduces these dream-acting behaviours.
- Participation involves sleep lab visits and careful monitoring of sleep and health.
- Anyone aged 18+ with iRBD can potentially join.
- This is an early-stage study to understand the medicine's effects better.
Who may be eligible?
This study is looking for adults aged 18 and over who have been diagnosed with isolated Rapid Eye Movement (REM) Behavior Disorder (iRBD). This means you have a specific sleep condition where you act out your dreams.
Both men and women can take part in this research. The study aims to include a clear group of people with iRBD to properly understand how the new medication works for them.
- Are you 18 years old or older?
- Have you been diagnosed with isolated Rapid Eye Movement (REM) Behavior Disorder (iRBD)?
- Are you able to attend overnight sleep lab visits?
- Are you comfortable taking a new study medication?
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 will be given the experimental medication, piromelatine. You'll have several visits to a sleep laboratory where your sleep will be carefully monitored. This involves wearing sensors that record your brain waves, eye movements, and muscle activity while you sleep. These recordings help researchers understand your sleep patterns and how the medication is affecting your symptoms. You will also fill out questionnaires about your sleep quality and how you feel generally. Throughout the study, your overall health will be checked, including vital signs, physical examinations, and blood tests. Researchers will also keep track of any side effects you might experience. The total length of your participation in the study has not been specifically detailed here, but clinical trials usually involve a few visits over several weeks or months.
Potential risks and benefits
Locations (1)
- —Austria
Common questions
What is iRBD?
iRBD stands for isolated Rapid Eye Movement Behavior Disorder. It's a sleep condition where you act out your dreams during REM sleep instead of your body being still.
What is piromelatine?
Piromelatine is a new medication being tested in this study to see if it can help reduce the symptoms of iRBD.
Will I have to stay overnight in a hospital?
Yes, your sleep will be monitored in a special sleep laboratory, which usually involves overnight stays, to carefully observe your sleep patterns and how the medication affects them.
Is this a new medication?
Yes, this is an early-stage (Phase II) study, meaning piromelatine is still being tested to understand its effectiveness and safety in patients.
Will I know if the medication is working?
The study team will be monitoring your symptoms and sleep patterns closely. They will discuss your progress with you, but the main goal is to gather information for the study as a whole.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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