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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

15 criteria

  • 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)
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Investigated drugs

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.

What is already known about the treatment

TAK-360 - An investigational medication currently being studied in clinical trials for the treatment of Idiopathic Hypersomnia (IH), a sleep disorder characterized by excessive daytime sleepiness. The medication is being evaluated in a randomized, double-blind, placebo-controlled study to determine its optimal dosing, safety profile, and effectiveness. While the specific mechanism of action and form of administration are not yet publicly disclosed in the available trial data, the drug is being investigated primarily for its potential to address symptoms of IH, with a focus on establishing its safety and tolerability through monitoring of treatment-related adverse events.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517712-29-00Protocol codeTAK-360-2002Estimated enrolment102 patientsSponsorTakeda Development Center Americas Inc.

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