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A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Sponsor: Takeda
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 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 with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that 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.
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2025-05-06
Completion Date
2026-08-20
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
TAK-360
TAK-360 tablet.
Placebo
TAK-360 matching placebo tablet.
Locations (52)
Takeda Site 36
Auburn, Alabama, United States
Takeda Site 39
Chandler, Arizona, United States
Takeda Site 40
Chula Vista, California, United States
Takeda Site 14
Redwood City, California, United States
Takeda Site 10
Santa Ana, California, United States
Takeda Site 1
Colorado Springs, Colorado, United States
Takeda Site 48
Bradenton, Florida, United States
Takeda Site 13
Brandon, Florida, United States
Takeda Site 46
Jacksonville, Florida, United States
Takeda Site 44
Miami, Florida, United States
Takeda Site 35
Miami, Florida, United States
Takeda Site 3
Orlando, Florida, United States
Takeda Site 33
Orlando, Florida, United States
Takeda Site 32
Atlanta, Georgia, United States
Takeda Site 49
Bowie, Maryland, United States
Takeda Site 50
Lansing, Michigan, United States
Takeda Site 34
Lathrup Village, Michigan, United States
Takeda Site 4
St Louis, Missouri, United States
Takeda Site 37
Middletown, New Jersey, United States
Takeda Site 8
Denver, North Carolina, United States
Takeda Site 6
Huntersville, North Carolina, United States
Takeda Site 41
Winston-Salem, North Carolina, United States
Takeda Site 5
Cincinnati, Ohio, United States
Takeda Site 45
Cleveland, Ohio, United States
Takeda Site 2
Columbia, South Carolina, United States
Takeda Site 38
Austin, Texas, United States
Takeda Site 43
Dallas, Texas, United States
Takeda Site 42
El Paso, Texas, United States
Takeda Site 47
Mansfield, Texas, United States
Takeda Site 7
San Antonio, Texas, United States
Takeda Site 11
Norfolk, Virginia, United States
Takeda Site 28
Beijing, Beijing Municipality, China
Takeda Site 29
Guangzhou, Guangzhou, China
Takeda Site 51
Changchun, Jilin, China
Takeda Site 27
Shanghai, Shanghai Municipality, China
Takeda Site 17
Montpellier, Hérault, France
Takeda Site 15
Paris, France
Takeda Site 22
Rome, Lazio, Italy
Takeda Site 31
Verona, Veneto, Italy
Takeda Site 23
Bologna, Italy
Takeda Site 24
Kohoku-ku, Yokohama-Shi, Kanagawa, Japan
Takeda Site 9
Kumamoto, Kumamoto, Japan
Takeda Site 53
Isahaya-shi, Nagasaki, Japan
Takeda Site 30
Urasoe-Shi, Okinawa, Japan
Takeda Site 20
Shinjuku-ku, Tokyo, Japan
Takeda Site 26
Sumida-Ku, Tokyo, Japan
Takeda Site 52
Fukuoka, Japan
Takeda Site 12
Yodogawa-ku, Osaka-shi, Ôsaka, Japan
Takeda Site 16
Junggu, Daegu Gwang'yeogsi, South Korea
Takeda Site 19
Suwon, Gyeonggido, South Korea
Takeda Site 21
Seoul, Seoul Teugbyeolsi, South Korea
Takeda Site 18
Madrid, Spain