A Study of TAK-360 in Adults With Idiopathic Hypersomnia
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
Interventions
TAK-360
Placebo
Conditions
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