A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Last updated: February 6, 2026
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Disorders

Idiopathic Hypersomnia

Treatment

TAK-360

Placebo

Clinical Study ID

NCT06812078
TAK-360-2002
2024-517712-29-00
jRCT2031240669
  • Ages 18-70
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a bodymass 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

Key Exclusion Criteria:

  1. The participant has a current medical disorder associated with excessive daytimesleepiness (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 doesnot apply to participants with carcinoma in situ [such as basal cell carcinoma] thathas 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 testresult: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (atscreening), 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 asingle febrile seizure in childhood).

  7. The participant has a history of cerebral ischemia, transient ischemic attack (lessthan [<]5 years from screening), intracranial aneurysm, or arteriovenousmalformation.

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: TAK-360
Phase: 2
Study Start date:
February 07, 2025
Estimated Completion Date:
July 16, 2026

Connect with a study center

  • Takeda Site 1

    Montpellier, Hrault
    France

    Site Not Available

  • Takeda Site 1

    Montpellier 2992166, Hrault
    France

    Active - Recruiting

  • Takeda Site 3

    Nantes, Pays De Loire 44093
    France

    Site Not Available

  • Takeda Site 3

    Nantes 2990969, Pays de Loire 44093
    France

    Active - Recruiting

  • Takeda Site 2

    Paris, 75013
    France

    Site Not Available

  • Takeda Site 2

    Paris 2988507, 75013
    France

    Active - Recruiting

  • Takeda Site 4

    Sha Tin,
    Hong Kong

    Site Not Available

  • Takeda Site 4

    Shatin 1818920,
    Hong Kong

    Active - Recruiting

  • Takeda Site 6

    Pozzilli, Isernia
    Italy

    Site Not Available

  • Takeda Site 6

    Pozzilli 3170006, Isernia
    Italy

    Active - Recruiting

  • Takeda Site 7

    Rome, Roma 00133
    Italy

    Site Not Available

  • Takeda Site 7

    Rome 3169070, Roma 00133
    Italy

    Active - Recruiting

  • Takeda Site 26

    Verona, Veneto
    Italy

    Site Not Available

  • Takeda Site 26

    Verona 3164527, Veneto 3164604
    Italy

    Active - Recruiting

  • Takeda Site 5

    Bologna, 40139
    Italy

    Site Not Available

  • Takeda Site 5

    Bologna 3181928, 40139
    Italy

    Active - Recruiting

  • Takeda Site 25

    Fukuoka-Shi Hakata-Ku, Fukuoka 1863958 812-0025
    Japan

    Active - Recruiting

  • Takeda Site 23

    Kurume-shi, Fukuoka 1863958 830-0011
    Japan

    Active - Recruiting

  • Takeda Site 22

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

    Site Not Available

  • Takeda Site 22

    Kohoku-ku, Yokohama-Shi 1848354, Kanagawa 1860291 222-0033
    Japan

    Active - Recruiting

  • Takeda Site 20

    Kumamoto-shi, Kumamoto 862-0954
    Japan

    Site Not Available

  • Takeda Site 20

    Kumamoto 1858421, Kumamoto 1858419 862-0954
    Japan

    Active - Recruiting

  • Takeda Site 21

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

    Site Not Available

  • Takeda Site 21

    Yodogawa-ku, Osaka-shi 1853909, Osaka 1853904 532-0003
    Japan

    Active - Recruiting

  • Takeda Site 24

    Bunkyo-ku, Tokyo 1850144 112-0012
    Japan

    Active - Recruiting

  • Takeda Site 9

    Vitoria, Alava 1004
    Spain

    Site Not Available

  • Takeda Site 9

    Vitoria-Gasteiz 3104499, Alava 1004
    Spain

    Active - Recruiting

  • Takeda Site 8

    Madrid, 28043
    Spain

    Site Not Available

  • Takeda Site 8

    Madrid 3117735, 28043
    Spain

    Active - Recruiting

  • Takeda Site 11

    Redwood City, California 94063
    United States

    Site Not Available

  • Takeda Site 10

    Santa Ana, California 92705
    United States

    Site Not Available

  • Takeda Site 11

    Redwood City 5386834, California 5332921 94063
    United States

    Active - Recruiting

  • Takeda Site 10

    Santa Ana 5392900, California 5332921 92705
    United States

    Active - Recruiting

  • Takeda Site 27

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • Takeda Site 27

    Colorado Springs 5417598, Colorado 5417618 80918
    United States

    Active - Recruiting

  • Takeda Site 19

    Brandon, Florida 33511
    United States

    Site Not Available

  • Takeda Site 14

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Takeda Site 19

    Brandon 4148757, Florida 4155751 33511
    United States

    Active - Recruiting

  • Takeda Site 14

    Winter Park 4178560, Florida 4155751 32789
    United States

    Active - Recruiting

  • Takeda Site 29

    Saint Louis, Missouri 63123
    United States

    Site Not Available

  • Takeda Site 29

    St Louis 4407066, Missouri 4398678 63123
    United States

    Active - Recruiting

  • Takeda Site 16

    Denver, North Carolina 28037
    United States

    Site Not Available

  • Takeda Site 15

    Huntersville, North Carolina 28078-5082
    United States

    Site Not Available

  • Takeda Site 16

    Denver 4463523, North Carolina 4482348 28037
    United States

    Site Not Available

  • Takeda Site 15

    Huntersville 4472370, North Carolina 4482348 28078-5082
    United States

    Active - Recruiting

  • Takeda Site 12

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • Takeda Site 17

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Takeda Site 12

    Cincinnati 4508722, Ohio 5165418 45245
    United States

    Active - Recruiting

  • Takeda Site 17

    Cincinnati 4508722, Ohio 5165418 45245
    United States

    Active - Recruiting

  • Takeda Site 13

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Takeda Site 13

    Columbia 4575352, South Carolina 4597040 29201
    United States

    Active - Recruiting

  • Takeda Site 18

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Takeda Site 18

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Takeda Site 28

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Takeda Site 28

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Active - Recruiting

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