RecruitingPHASE2INTERVENTIONAL

A Study of TAK-360 in Adults With Idiopathic Hypersomnia

This study is investigating a new medicine, TAK-360, for adults living with Idiopathic Hypersomnia (IH). IH is a condition where people feel incredibly sleepy during the day, even after a long night's sleep, making daily life tricky. Our brains naturally produce a chemical called orexin that helps us stay awake, and TAK-360 is designed to act like this chemical.\n\nThe main goals of this study are to understand how safe TAK-360 is and how well people with IH tolerate it. We also want to find out if it helps them feel more awake and what dose might be most effective. Participants will be randomly chosen to receive either TAK-360 or a placebo (a dummy medicine with no active ingredient) to help us understand the true effects of the real medicine.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Takeda

Enrolment target

Start

07 Feb 2025

Estimated completion

16 Jul 2026

Idiopathic Hypersomnia

What is this study about?

Imagine feeling incredibly tired all the time, even if you’ve slept for many hours. That’s what life can be like for someone with Idiopathic Hypersomnia, or IH. People with IH often struggle to wake up, feel sleepy throughout the day (sometimes sleeping more than 11 hours), and find that naps don't help much. This can make it hard to concentrate, think clearly, and keep up with daily activities. Some might even feel dizzy.

Our brains make a natural chemical called orexin, which plays a big part in keeping us awake and alert. Scientists have developed a new medicine called TAK-360 that is designed to work in a similar way to orexin. Early research has shown that medicines like TAK-360 might help people stay awake.

This study aims to discover a few key things about TAK-360. Firstly, we want to make sure it’s safe for people with IH and that they can take it without too many uncomfortable side effects. Secondly, we want to see if TAK-360 actually helps people with IH feel more awake and what amount of the medicine might be best to achieve this.

Key takeaways

This study is for adults with Idiopathic Hypersomnia (IH).
It's testing a new medicine, TAK-360, that mimics a wakefulness chemical.
The main goals are to check safety, tolerability, and if it helps reduce sleepiness.
Participants will be randomly assigned to TAK-360 or a placebo.
Your health and well-being will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old. You should have a confirmed diagnosis of Idiopathic Hypersomnia (IH), meaning a doctor has already told you that you have this condition.

There are also a few health conditions that would mean you can't take part. For example, if you have other medical problems that cause you to be very sleepy during the day (apart from IH), this study might not be right for you. Also, certain serious illnesses or recent health issues, such as specific thyroid problems, some cancers within the last 5 years (excluding certain skin cancers), or definite signs of certain viral infections like Hepatitis B or C, would prevent you from joining.

Similarly, if you've had a significant head injury, epilepsy, seizures (unless it's a single fever-related seizure as a child), or certain brain-related health issues like a stroke or specific brain blood vessel problems, you wouldn't be able to participate.

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 70 years old?
Have you been officially diagnosed with Idiopathic Hypersomnia (IH)?
Do you currently have any other major health conditions that cause severe daytime sleepiness (apart from IH)?
Have you been free from specific serious illnesses like certain cancers (within 5 years) or some serious viral infections?
Do you have a history of seizures (other than a single childhood fever seizure) or certain brain health issues?
Is your body weight within the specified range (BMI between 16 and 38 kg/m2)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like drawing names from a hat) to receive either TAK-360 or a placebo. A placebo looks exactly like the study medicine but doesn't contain any active drug. This helps researchers understand the true effect of TAK-360.

The study involves regular visits to the clinic where you’ll have various health checks and assessments. These might include blood tests, physical examinations, and different tests to measure your sleepiness and how well you’re staying awake. You’ll be asked to take the study medicine (or placebo) as instructed by the study team.

Throughout the study, the research team will monitor your health closely and ask you about any side effects you might experience. There will also be follow-up appointments after you stop taking the study medicine to ensure your well-being. The total length of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as contributing to medical knowledge and potentially helping future patients with Idiopathic Hypersomnia. For you personally, there is a chance that TAK-360 might reduce your daytime sleepiness, although there's no guarantee, especially if you receive the placebo. All medicines have potential risks, and TAK-360 may cause side effects, some of which could be unknown at this stage. The research team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

Takeda Site 11
Verified postcode
Redwood City, United States· Recruiting
Takeda Site 10
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Santa Ana, United States· Recruiting
Takeda Site 27
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Colorado Springs, United States· Recruiting
Takeda Site 19
Verified postcode
Brandon, United States· Recruiting
Takeda Site 14
Verified postcode
Winter Park, United States· Recruiting
Takeda Site 29
Verified postcode
St Louis, United States· Recruiting
Takeda Site 16
Verified postcode
Denver, United States· Recruiting
Takeda Site 15
Verified postcode
Huntersville, United States· Recruiting
Takeda Site 12
Verified postcode
Cincinnati, United States· Recruiting
Takeda Site 17
Verified postcode
Cincinnati, United States· Recruiting
Takeda Site 13
Verified postcode
Columbia, United States· Recruiting
Takeda Site 18
Verified postcode
San Antonio, United States· Recruiting

Common questions

What is Idiopathic Hypersomnia (IH)?

IH is a condition where people feel very sleepy during the day, even after getting a lot of sleep at night, and naps don't make them feel rested.

What is TAK-360?

TAK-360 is a new medicine being tested. It's designed to act like a natural brain chemical called orexin, which helps us stay awake and alert.

Will I definitely get the new medicine?

No, you'll be randomly chosen to receive either TAK-360 or a placebo (a dummy medicine with no active ingredient). This is so we can accurately see the medicine's effects.

Why is a placebo used?

Using a placebo helps researchers compare reactions to the real medicine against reactions to no medicine, showing us if TAK-360 truly makes a difference.

What are the main goals of this study?

The study aims to find out if TAK-360 is safe, how well people tolerate it, and if it helps reduce daytime sleepiness for people with IH.

How to find out more

Takeda Contact

medinfous@takeda.com +1-877-825-3327 Official trial record

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