Actively Recruiting
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Led by Takeda · Updated on 2026-03-24
96
Participants Needed
29
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant weighs at least 40 kilograms and has a body mass index between 16 and 38 inclusive
- Participant has a documented, current diagnosis of idiopathic hypersomnia
- Participant is aged 18 to 70 years
You will not qualify if you...
- Participant has a current medical disorder causing excessive daytime sleepiness other than idiopathic hypersomnia
- Participant has medically significant thyroid disease
- Participant has a history of cancer in the past 5 years, except treated and stable carcinoma in situ
- Participant tests positive for hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody/antigen at screening
- Participant has a clinically significant history of head injury or head trauma
- Participant has history of epilepsy, seizure, or convulsion (except a single febrile seizure in childhood)
- Participant has history of cerebral ischemia, transient ischemic attack within less than 5 years, intracranial aneurysm, or arteriovenous malformation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 29 locations
1
Takeda Site 11
Redwood City, California, United States, 94063
Actively Recruiting
2
Takeda Site 10
Santa Ana, California, United States, 92705
Actively Recruiting
3
Takeda Site 27
Colorado Springs, Colorado, United States, 80918
Actively Recruiting
4
Takeda Site 19
Brandon, Florida, United States, 33511
Actively Recruiting
5
Takeda Site 14
Winter Park, Florida, United States, 32789
Actively Recruiting
6
Takeda Site 29
St Louis, Missouri, United States, 63123
Actively Recruiting
7
Takeda Site 16
Denver, North Carolina, United States, 28037
Actively Recruiting
8
Takeda Site 15
Huntersville, North Carolina, United States, 28078-5082
Actively Recruiting
9
Takeda Site 12
Cincinnati, Ohio, United States, 45245
Actively Recruiting
10
Takeda Site 17
Cincinnati, Ohio, United States, 45245
Actively Recruiting
11
Takeda Site 13
Columbia, South Carolina, United States, 29201
Actively Recruiting
12
Takeda Site 18
San Antonio, Texas, United States, 78229
Actively Recruiting
13
Takeda Site 28
Norfolk, Virginia, United States, 23507
Actively Recruiting
14
Takeda Site 1
Montpellier, Hrault, France
Actively Recruiting
15
Takeda Site 3
Nantes, Pays de Loire, France, 44093
Actively Recruiting
16
Takeda Site 2
Paris, France, 75013
Actively Recruiting
17
Takeda Site 4
Shatin, Hong Kong
Withdrawn
18
Takeda Site 6
Pozzilli, Isernia, Italy
Actively Recruiting
19
Takeda Site 7
Rome, Roma, Italy, 00133
Actively Recruiting
20
Takeda Site 26
Verona, Veneto, Italy
Actively Recruiting
21
Takeda Site 5
Bologna, Italy, 40139
Actively Recruiting
22
Takeda Site 25
Fukuoka-Shi Hakata-Ku, Fukuoka, Japan, 812-0025
Actively Recruiting
23
Takeda Site 23
Kurume-shi, Fukuoka, Japan, 830-0011
Actively Recruiting
24
Takeda Site 22
Kohoku-ku, Yokohama-Shi, Kanagawa, Japan, 222-0033
Actively Recruiting
25
Takeda Site 20
Kumamoto, Kumamoto, Japan, 862-0954
Actively Recruiting
26
Takeda Site 21
Yodogawa-ku, Osaka-shi, Osaka, Japan, 532-0003
Actively Recruiting
27
Takeda Site 24
Bunkyo-ku, Tokyo, Japan, 112-0012
Actively Recruiting
28
Takeda Site 9
Vitoria-Gasteiz, Alava, Spain, 1004
Actively Recruiting
29
Takeda Site 8
Madrid, Spain, 28043
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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