Study of TAK-360 tablets to evaluate safety and effectiveness in people with Idiopathic Hypersomnia

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What is this study about?

This study focuses on Idiopathic Hypersomnia (IH), a sleep disorder characterized by excessive daytime sleepiness despite getting normal or long amounts of nighttime sleep. The research evaluates a new medication called TAK-360, which is being tested as a potential treatment for this condition. The medication comes in tablet form and is taken by mouth.

The purpose of this research is to determine if TAK-360 is safe and well-tolerated by people with Idiopathic Hypersomnia. The study will compare TAK-360 tablets with placebo to understand how effective the medication is in treating the symptoms of Idiopathic Hypersomnia. The treatment period will last for 4 weeks.

During the study, participants will be randomly assigned to receive either TAK-360 or placebo. Neither the participants nor the doctors will know which treatment is being given. The study will monitor how participants respond to the treatment by measuring changes in their daytime sleepiness and other symptoms related to Idiopathic Hypersomnia. The researchers will also track any side effects that may occur during the treatment period.

1 Initial phase

The study evaluates TAK-360, a medication for idiopathic hypersomnia (IH) – a condition that causes excessive daytime sleepiness

The total duration of the study is from June 2025 to April 2026

Participation is possible for individuals aged 18-70 years who weigh at least 40 kg and have a BMI between 16 and 38

A diagnosis of idiopathic hypersomnia within the last 5 years is required

2 Treatment administration

You will receive either TAK-360 tablets or a placebo (inactive tablet)

The medication is taken orally

Neither you nor the study staff will know which treatment you are receiving during the study

3 Monitoring period

The study will monitor any side effects that may occur during treatment

Your sleepiness levels will be measured using two scales:

The ESS (Epworth Sleepiness Scale) – which measures daytime sleepiness

The IHSS (Idiopathic Hypersomnia Severity Scale) – which measures hypersomnia symptoms

4 Assessment phase

After 4 weeks, changes in your sleepiness levels will be evaluated

The evaluation compares your initial symptoms to those after treatment

The assessment includes comparing results between participants who received TAK-360 and those who received placebo

Who Can Join the Study?

Must be between 18 and 70 years old when signing the informed consent form
Must have a body weight of at least 40 kilograms
Must have a Body Mass Index (BMI) between 16 and 38 (BMI is a measure of body fat based on height and weight)
Must have been diagnosed with Idiopathic Hypersomnia (IH) within the past 5 years
Both men and women can participate in the study
Must not belong to any vulnerable population groups (such as prisoners, mentally disabled persons, or other protected groups)

Who Cannot Join the Study?

Age below 18 or above 65 years
Pregnant or breastfeeding women
History of severe allergic reactions to medications
Current participation in other clinical trials
Diagnosed with any other sleep disorders besides Idiopathic Hypersomnia
Serious medical conditions affecting heart, liver, or kidneys
Use of medications that may interact with the study drug
History of substance abuse within the past 12 months
Mental health conditions that could affect the study results
Irregular sleep patterns due to shift work
Inability to follow study procedures or attend scheduled visits
Abnormal blood test results that could indicate health issues
Uncontrolled high blood pressure
History of seizures or epilepsy
Recent major surgery (within past 3 months)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
Hospital Universitario Araba	Vitoria	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.06.2025
Italy	Recruiting	15.06.2025
Spain	Recruiting	15.06.2025

Trial locations

TAK-360 is an investigational medication being studied for people with idiopathic hypersomnia, a condition that causes excessive daytime sleepiness. This new drug is being tested to understand how safe it is and how well patients can tolerate it. The medication is still in development, and researchers are working to find the right dose that provides the best balance of effectiveness and safety.

Idiopathic Hypersomnia – A chronic neurological sleep disorder characterized by excessive daytime sleepiness despite getting normal or long amounts of sleep at night. People with this condition often experience great difficulty waking up, severe sleep inertia (sleep drunkenness), and the persistent urge to sleep throughout the day. The condition can include prolonged nighttime sleep episodes lasting more than 10 hours, unrefreshing naps, and cognitive dysfunction such as brain fog or memory issues. Unlike narcolepsy, this disorder is not associated with sudden loss of muscle tone or sleep attacks. The exact cause remains unknown, hence the term “idiopathic.”

Trial ID:

2024-517712-29-00

Protocol code:

TAK-360-2002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of TAK-360 tablets to evaluate safety and effectiveness in people with Idiopathic Hypersomnia

What is this study about?

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