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โ† Trials
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A Study of TAK-360 in Adults With Idiopathic Hypersomnia

RecruitingPhase 2Ages 18 Years - 70 YearsAllTakeda
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In plain words

What the trial is, and whether it could suit you

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 an

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. The participant weighs greater than or equal to (โ‰ฅ) 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.
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What it tests

  • TAK-360
  • Placebo
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Where

29 sites
Takeda Site 11
Redwood City, United States
Takeda Site 10
Santa Ana, United States
Takeda Site 27
Colorado Springs, United States
Takeda Site 19
Brandon, United States
Takeda Site 14
Winter Park, United States
Takeda Site 29
St Louis, United States
Takeda Site 16
Denver, United States
Takeda Site 15
Huntersville, United States

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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