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A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

RecruitingPhase 2Ages 18 Years - 70 YearsAllTakeda
NCT06952699 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. 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 NT2 tolerate it. Researchers also want to find out if TAK-360 can help people wi

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📋 Eligibility rules (as published)
Key Inclusion Criteria: 1. The participant weighs greater than equal or 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 NT2. Key Exclusion Criteria: 1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2. 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 (HCV) 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 (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
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What it tests

  • TAK-360
  • Placebo
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Where

52 sites
Takeda Site 36
Auburn, United States
Takeda Site 39
Chandler, United States
Takeda Site 40
Chula Vista, United States
Takeda Site 14
Redwood City, United States
Takeda Site 10
Santa Ana, United States
Takeda Site 1
Colorado Springs, United States
Takeda Site 48
Bradenton, United States
Takeda Site 13
Brandon, United States

…and 44 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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