Status:
RECRUITING
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Lead Sponsor:
Takeda
Conditions:
Narcolepsy Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- Key
- 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) \[inclusive\].
- The participant has a documented, current diagnosis of NT2.
- Key
Exclusion
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
- The participant has medically significant thyroid disease.
- 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).
- 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).
- The participant has a clinically significant history of head injury or head trauma.
- The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
- The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06952699
Start Date
May 6 2025
End Date
April 23 2026
Last Update
November 3 2025
Active Locations (29)
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1
Takeda Site 14
Redwood City, California, United States, 94063-3132
2
Takeda Site 10
Santa Ana, California, United States, 92705-8519
3
Takeda Site 1
Colorado Springs, Colorado, United States, 80918-3408
4
Takeda Site 13
Brandon, Florida, United States, 33511-5719