A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Last updated: March 5, 2025
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: 40
Treatment Group(s): 2
Primary Treatment: TAK-360
Phase: 2
Study Start date:
February 07, 2025
Estimated Completion Date:
February 19, 2026

Connect with a study center

  • Takeda Site 1

    Montpellier, Hrault
    France

    Site Not Available

  • Takeda Site 3

    Nantes, Pays De Loire 44093
    France

    Site Not Available

  • Takeda Site 2

    Paris, 75013
    France

    Site Not Available

  • Takeda Site 4

    Sha Tin,
    Hong Kong

    Site Not Available

  • Takeda Site 6

    Pozzilli, Isernia
    Italy

    Site Not Available

  • Takeda Site 7

    Rome, Roma 00133
    Italy

    Site Not Available

  • Takeda Site 5

    Bologna, 40139
    Italy

    Site Not Available

  • Takeda Site 25

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

    Site Not Available

  • Takeda Site 23

    Kurume-shi, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Takeda Site 22

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

    Active - Recruiting

  • Takeda Site 20

    Kumamoto-shi, Kumamoto 862-0954
    Japan

    Active - Recruiting

  • Takeda Site 21

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

    Site Not Available

  • Takeda Site 24

    Bunkyo-ku, Tokyo 112-0012
    Japan

    Site Not Available

  • Takeda Site 9

    Vitoria, Alava 1004
    Spain

    Site Not Available

  • Takeda Site 8

    Madrid, 28043
    Spain

    Site Not Available

  • Takeda Site 11

    Redwood City, California 94063
    United States

    Site Not Available

  • Takeda Site 10

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Takeda Site 19

    Brandon, Florida 33511
    United States

    Site Not Available

  • Takeda Site 14

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Takeda Site 16

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • Takeda Site 15

    Huntersville, North Carolina 28078-5082
    United States

    Active - Recruiting

  • Takeda Site 12

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Takeda Site 17

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Takeda Site 13

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Takeda Site 18

    San Antonio, Texas 78229
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.