Actively Recruiting
A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Adults With Idiopathic Hypersomnia
Led by Takeda · Updated on 2026-03-24
96
Participants Needed
29
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Idiopathic Hypersomnia (IH) is a condition where adults feel extremely sleepy during the day, especially in the morning, even if they get a lot of sleep at night. People with IH may struggle to wake up, feel tired despite naps, and experience difficulty focusing or completing daily tasks. This trial is designed to evaluate the safety, tolerability, and potential benefits of TAK-360, a drug that acts like orexin, a brain chemical that helps maintain wakefulness, in adults with IH. Participants in the study will be randomly assigned to receive either TAK-360 tablets or placebo tablets, which look the same but contain no active medicine, for a period of 4 weeks. This randomized, double-blind design means neither participants nor researchers will know who receives the active drug or placebo during the trial, helping to fairly assess TAK-360's effects. During the study, participants will be monitored for any treatment-related side effects up to 8 weeks. Researchers will measure changes in sleepiness using the Epworth Sleepiness Scale and changes in IH symptoms using the Idiopathic Hypersomnia Severity Scale at the start and after 4 weeks of treatment. The trial lasts several weeks, including follow-up, to understand how TAK-360 affects safety, wakefulness, and symptom severity in IH.
CONDITIONS
Brief Title
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must weigh at least 40 kilograms and have a body mass index (BMI) between 16 and 38 kg/m² inclusive
- Participants must have a documented, current diagnosis of idiopathic hypersomnia
- Participants must be between 18 and 70 years old
You will not qualify if you...
- Participants with a current medical disorder causing excessive daytime sleepiness other than idiopathic hypersomnia
- Participants with medically significant thyroid disease
- Participants with cancer history in the past 5 years, except treated and stable carcinoma in situ such as basal cell carcinoma (approval needed)
- Participants with positive tests for hepatitis B, hepatitis C, or HIV at screening
- Participants with a clinically significant history of head injury or trauma
- Participants with a history of epilepsy, seizures, or convulsions, except a single febrile seizure in childhood
- Participants with history of cerebral ischemia, transient ischemic attack within 5 years, intracranial aneurysm, or arteriovenous malformation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive TAK-360 tablets or matching placebo tablets orally for idiopathic hypersomnia.
Weekly visits for up to 4 weeks
Duration - Up to 4 weeks after treatment
Participants are monitored for safety and outcomes after treatment ends.
1 to 2 visits depending on safety assessments
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
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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