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Idiopathic HypersomniaPhase 2NCT06812078

A Study of TAK-360 in Adults With Idiopathic Hypersomnia

A Phase 2 study testing TAK-360 in people with Idiopathic Hypersomnia, run by Takeda at 29 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Idiopathic Hypersomnia
What is being tested?
TAK-360
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
29 sitesin 6 countries
Study dates
7 Feb 2025to 30 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m^2) [inclusive].
  • The participant has a documented, current diagnosis of IH.

Who cannot join

  • The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH].
  • The participant has medically significant thyroid disease.
  • The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
  • The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
  • The participant has a clinically significant history of head injury or head trauma.
  • The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
  • The participant has a history of cerebral ischemia, transient ischemic attack (less than [<]5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Trial locations and contacts

29 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

29 sites in 6 countries

United States13 sites, 13 recruiting

  • Takeda Site 19

    Brandon, Florida, 33511

    Recruiting

  • Takeda Site 12

    Cincinnati, Ohio, 45245

    Recruiting

  • Takeda Site 17

    Cincinnati, Ohio, 45245

    Recruiting

  • Takeda Site 27

    Colorado Springs, Colorado, 80918

    Recruiting

  • Takeda Site 13

    Columbia, South Carolina, 29201

    Recruiting

  • Takeda Site 16

    Denver, North Carolina, 28037

    Recruiting

  • Takeda Site 15

    Huntersville, North Carolina, 28078-5082

    Recruiting

  • Takeda Site 28

    Norfolk, Virginia, 23507

    Recruiting

  • Takeda Site 11

    Redwood City, California, 94063

    Recruiting

  • Takeda Site 18

    San Antonio, Texas, 78229

    Recruiting

  • Takeda Site 10

    Santa Ana, California, 92705

    Recruiting

  • Takeda Site 29

    St Louis, Missouri, 63123

    Recruiting

  • Takeda Site 14

    Winter Park, Florida, 32789

    Recruiting

Other trials in United States

Japan6 sites, 6 recruiting

  • Takeda Site 24

    Bunkyo-ku, Tokyo, 112-0012

    Recruiting

  • Takeda Site 25

    Fukuoka-Shi Hakata-Ku, Fukuoka, 812-0025

    Recruiting

  • Takeda Site 22

    Kohoku-ku, Yokohama-Shi, Kanagawa, 222-0033

    Recruiting

  • Takeda Site 20

    Kumamoto, Kumamoto, 862-0954

    Recruiting

  • Takeda Site 23

    Kurume-shi, Fukuoka, 830-0011

    Recruiting

  • Takeda Site 21

    Yodogawa-ku, Osaka-shi, Osaka, 532-0003

    Recruiting

Other trials in Japan

Italy4 sites, 4 recruiting

  • Takeda Site 5

    Bologna, 40139

    Recruiting

  • Takeda Site 6

    Pozzilli, Isernia

    Recruiting

  • Takeda Site 7

    Rome, Roma, 00133

    Recruiting

  • Takeda Site 26

    Verona, Veneto

    Recruiting

Other trials in Italy

France3 sites, 3 recruiting

  • Takeda Site 1

    Montpellier, Hrault

    Recruiting

  • Takeda Site 3

    Nantes, Pays de Loire, 44093

    Recruiting

  • Takeda Site 2

    Paris, 75013

    Recruiting

Other trials in France

Spain2 sites, 2 recruiting

  • Takeda Site 8

    Madrid, 28043

    Recruiting

  • Takeda Site 9

    Vitoria-Gasteiz, Alava, 1004

    Recruiting

Other trials in Spain

Hong Kong1 site

  • Takeda Site 4

    Shatin

    Withdrawn

Other trials in Hong Kong

About this study

Official title: A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)

Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.

The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that.

Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

Being tested
TAK-360, Placebo
Keywords
Idiopathic Hypersomnia, TAK-360
Medical subject headings
Idiopathic Hypersomnia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-360Drug

    TAK-360 tablet.

  • PlaceboOther

    TAK-360 matching placebo tablet.

Study groups in NCT06812078
Study groupRoleWhat they receive
TAK-360ExperimentalParticipants will receive TAK-360 tablets, orally, for 4 weeks.
Receives: Drug: TAK-360
PlaceboPlacebo comparatorParticipants will receive TAK-360 matching placebo tablets, orally, for 4 weeks.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

    Measured: Up to Week 8

Secondary outcomes (2)

  1. Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score

    The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.

    Measured: Baseline, Week 4

  2. Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score

    IHSS is a 14-item self-assessment questionnaire, to measure the severity, frequency and functional impact of the three key IH symptoms (during a recall period of "past 7 days"). The IHSS includes 14 items in total; two items (1 and 2) on nighttime sleep duration and quality, three items (3, 4 and 5) on sleep inertia and sleep drunkenness after nighttime sleep and one (8) after daytime nap, and three items (6, 7 and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10 to 14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and eight items on a 4-point Likert scale; the Likert scale is a point scale which is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0 to 50), and higher scores indicate more severe symptoms.

    Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start7 Feb 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812078
Sponsor's protocol ID
TAK-360-2002
Other IDs
2024-517712-29-00, jRCT2031240669
Status last verified
Jul 2026
First submitted
3 Feb 2025
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-360 in people with Idiopathic Hypersomnia, run by Takeda at 29 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Japan, Italy, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06812078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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