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NCT06812078PHASE2Recruiting

A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Takeda

Start Date

2/7/2025

Completion Date

11/30/2026

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

Age Range: 18 years to 70 years

Key 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. Key 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.

Interventions

DRUG

TAK-360

OTHER

Placebo

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Conditions

Idiopathic Hypersomnia

Locations

Takeda Site 11

Redwood City, California 94063

United States

Takeda Site 10

Santa Ana, California 92705

United States

Takeda Site 27

Colorado Springs, Colorado 80918

United States

Takeda Site 19

Brandon, Florida 33511

United States

Takeda Site 14

Winter Park, Florida 32789

United States

Takeda Site 29

St Louis, Missouri 63123

United States

Takeda Site 16

Denver, North Carolina 28037

United States

Takeda Site 15

Huntersville, North Carolina 28078-5082

United States

Takeda Site 12

Cincinnati, Ohio 45245

United States

Takeda Site 17

Cincinnati, Ohio 45245

United States

Takeda Site 13

Columbia, South Carolina 29201

United States

Takeda Site 18

San Antonio, Texas 78229

United States

Takeda Site 28

Norfolk, Virginia 23507

United States

Takeda Site 1

Montpellier, Hrault

France

Takeda Site 3

Nantes, Pays de Loire 44093

France

Takeda Site 2

Paris, 75013

France

Takeda Site 4

Shatin,

Hong Kong

Takeda Site 6

Pozzilli, Isernia

Italy

Takeda Site 7

Rome, Roma 00133

Italy

Takeda Site 26

Verona, Veneto

Italy

Takeda Site 5

Bologna, 40139

Italy

Takeda Site 25

Fukuoka-Shi Hakata-Ku, Fukuoka 812-0025

Japan

Takeda Site 23

Kurume-shi, Fukuoka 830-0011

Japan

Takeda Site 22

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

Japan

Takeda Site 20

Kumamoto, Kumamoto 862-0954

Japan

Takeda Site 21

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

Japan

Takeda Site 24

Bunkyo-ku, Tokyo 112-0012

Japan

Takeda Site 9

Vitoria-Gasteiz, Alava 1004

Spain

Takeda Site 8

Madrid, 28043

Spain