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A Study of TAK-360 in Adults With Idiopathic Hypersomnia

NCT ID: NCT06812078

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-07

Study Completion Date

2026-07-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Hypersomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAK-360

Participants will receive TAK-360 tablets, orally, for 4 weeks.

Group Type EXPERIMENTAL

TAK-360

Intervention Type DRUG

TAK-360 tablet.

Placebo

Participants will receive TAK-360 matching placebo tablets, orally, for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

TAK-360 matching placebo tablet.

Interventions

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TAK-360

TAK-360 tablet.

Intervention Type DRUG

Placebo

TAK-360 matching placebo tablet.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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) \[inclusive\].
2. The participant has a documented, current diagnosis of IH.

Exclusion Criteria

1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) \[other than IH\].
2. The participant has medically significant thyroid disease.
3. 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.)
4. 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).
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (less than \[\<\]5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda Site 11

Redwood City, California, United States

Site Status RECRUITING

Takeda Site 10

Santa Ana, California, United States

Site Status RECRUITING

Takeda Site 27

Colorado Springs, Colorado, United States

Site Status RECRUITING

Takeda Site 19

Brandon, Florida, United States

Site Status RECRUITING

Takeda Site 14

Winter Park, Florida, United States

Site Status RECRUITING

Takeda Site 29

St Louis, Missouri, United States

Site Status RECRUITING

Takeda Site 16

Denver, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Takeda Site 15

Huntersville, North Carolina, United States

Site Status RECRUITING

Takeda Site 12

Cincinnati, Ohio, United States

Site Status RECRUITING

Takeda Site 17

Cincinnati, Ohio, United States

Site Status RECRUITING

Takeda Site 13

Columbia, South Carolina, United States

Site Status RECRUITING

Takeda Site 18

San Antonio, Texas, United States

Site Status RECRUITING

Takeda Site 28

Norfolk, Virginia, United States

Site Status RECRUITING

Takeda Site 1

Montpellier, Hrault, France

Site Status RECRUITING

Takeda Site 3

Nantes, Pays de Loire, France

Site Status RECRUITING

Takeda Site 2

Paris, , France

Site Status RECRUITING

Takeda Site 4

Shatin, , Hong Kong

Site Status RECRUITING

Takeda Site 6

Pozzilli, Isernia, Italy

Site Status RECRUITING

Takeda Site 7

Rome, Roma, Italy

Site Status RECRUITING

Takeda Site 26

Verona, Veneto, Italy

Site Status RECRUITING

Takeda Site 5

Bologna, , Italy

Site Status RECRUITING

Takeda Site 25

Fukuoka-Shi Hakata-Ku, Fukuoka, Japan

Site Status RECRUITING

Takeda Site 23

Kurume-shi, Fukuoka, Japan

Site Status RECRUITING

Takeda Site 22

Kohoku-ku, Yokohama-Shi, Kanagawa, Japan

Site Status RECRUITING

Takeda Site 20

Kumamoto, Kumamoto, Japan

Site Status RECRUITING

Takeda Site 21

Yodogawa-ku, Osaka-shi, Osaka, Japan

Site Status RECRUITING

Takeda Site 24

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Takeda Site 9

Vitoria-Gasteiz, Alava, Spain

Site Status RECRUITING

Takeda Site 8

Madrid, , Spain

Site Status RECRUITING

Countries

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United States France Hong Kong Italy Japan Spain

Central Contacts

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Takeda Contact

Role: CONTACT

[email protected]
+1-877-825-3327

Related Links

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https://clinicaltrials.takeda.com/study-detail/88ad04fc158b4d5a??page=1&idFilter=TAK-360-2002

Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Other Identifiers

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2024-517712-29-00

Identifier Type: CTIS

Identifier Source: secondary_id

jRCT2031240669

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-360-2002

Identifier Type: -

Identifier Source: org_study_id

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