Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy and tolerability of tasipimidine after 3 repeated bed-time doses in patients with insomnia disorder with a 4-week extension part

This research study is looking into a new liquid medicine called tasipimidine for people who have trouble sleeping, also known as insomnia. The main goal is to find out if taking tasipimidine a few times before bed helps people sleep longer without waking up and fall asleep more quickly. They are comparing different strengths of the medicine to a dummy medicine (placebo). Over several weeks, researchers will carefully monitor participants' sleep using special equipment in a sleep lab. They'll also check if the medicine causes any unwanted effects, like changes in blood pressure or morning sleepiness. This study aims to understand if tasipimidine could be a safe and effective new treatment for insomnia.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Orion Corporation

Enrolment target

272

Start

24 May 2023

Insomnia disorder

What is this study about?

This study is designed to explore a new potential treatment for insomnia, a condition where people have difficulty falling or staying asleep. The medicine being tested is called tasipimidine, and it's given as a liquid solution. We want to understand if this medicine can help people with insomnia sleep better and more consistently.

The main things we're looking at are how much time people spend awake after first falling asleep (which we call 'wake after sleep onset') and how long it takes them to drift off to sleep in the first place ('latency to persistent sleep'). To measure this accurately, participants will have their sleep monitored in a special sleep lab using equipment that records brain activity and other body functions during sleep. This helps us get a clear picture of how the medicine affects their sleep patterns.

We're also very interested in whether tasipimidine causes any side effects. Researchers will be checking participants' general health, including their heart rate and blood pressure, and looking for any signs of morning tiredness. This will help us understand if the medicine is safe and well-tolerated. The study involves different doses of the medicine, so we can see which dose might be most effective and safest for people with insomnia.

Key takeaways

This study is testing a new liquid medicine for insomnia.
It aims to see if the medicine helps people fall asleep faster and stay asleep longer.
Sleep will be carefully monitored in a sleep lab.
Researchers will also check for any side effects of the medicine.
The study involves comparing different doses to a dummy medicine (placebo).
It lasts for several weeks, including a four-week treatment period.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women are welcome to take part.

Since this study focuses on insomnia, you will need to have a formal diagnosis of insomnia (meaning a doctor has said you have it) and be experiencing ongoing sleep difficulties. There may be other specific health requirements or conditions that would prevent you from joining, which the study team will discuss with you.

It's important to have a chat with the study doctors to see if this trial is the right fit for you and if you meet all the necessary 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 at least 18 years old?
Have you been diagnosed with insomnia disorder?
Are you willing to take a liquid medicine before bed?
Are you able to attend several study visits, including overnight stays at a sleep lab?
Are you comfortable with regular health checks like blood pressure and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given one of three liquid solutions to take before bed: a low dose of the new medicine, a higher dose, or a dummy medicine (placebo). You won't know which one you're receiving. Over the course of the study, you'll have several visits, including overnight stays in a sleep lab. During these stays, special sensors will be used to monitor your sleep (this is called polysomnography).

You'll be asked to take the study medicine for a few nights initially, and then for a longer period of four weeks. Throughout this time, you'll have regular check-ups where doctors will ask about your sleep and how you're feeling. They'll also take measurements like your blood pressure and heart rate, and collect blood or urine samples for safety tests. The study lasts for several weeks in total, including the extended four-week treatment period and follow-up checks.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a new medicine that might improve your sleep, or having your sleep closely monitored by specialists. However, as with all medicines, there's a chance of side effects, which could include changes in your blood pressure or feeling sleepy in the morning. Some people might not experience any benefit from the medicine, especially if they are taking the placebo. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Finland
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Unverified
Poland
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Unverified
Germany

Common questions

What is insomnia disorder?

Insomnia disorder means you regularly have trouble falling or staying asleep, or you wake up too early and can't get back to sleep, leading to tiredness during the day.

What is ODM-105?

ODM-105 is the scientific name for the new medicine, tasipimidine, that is being tested in this study to see if it helps with insomnia.

What does 'placebo' mean?

A placebo is a dummy medicine that looks and tastes like the real medicine but contains no active drug. It helps researchers compare the real 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 team will know if you're receiving the active medicine or the placebo. This helps ensure fair results.

What are the sleep lab visits for?

The sleep lab visits involve special equipment that monitors your brain waves, breathing, and other body functions while you sleep to accurately measure how the medicine affects your sleep patterns.