A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
Start Date
6/4/2026
Completion Date
11/28/2027
Summary
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy). The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends. The participants will have to visit the clinic multiple times during this study.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
TAK-360
Placebo
Conditions
Locations
Takeda Site 12
Redwood City, California 94063
United States
Takeda Site 14
Miami, Florida 33176
United States
Takeda Site 13
Cincinnati, Ohio 45245
United States
Takeda Site 2
Macquarie Park, New South Wales 2113
Australia
Takeda Site 4
Beijing, Beijing Municipality 100053
China
Takeda Site 3
Guangzhou, Guangdong 510515
China
Takeda Site 5
Zhengzhou, Henan 450003
China
Takeda Site 6
Herault, Montpelier 34000
France
Takeda Site 7
Paris, 75013
France
Takeda Site 8
Bologna, Emilia-Romagna 40139
Italy
Takeda Site 9
Verona, Veneto 37134
Italy
Takeda Site 17
Fukuoka, Fukuoka 812-0025
Japan
Takeda Site 1
Kumamoto, Kumamoto 862-0954
Japan
Takeda Site 18
Isahaya-shi, Nagasaki 854-0081
Japan
Takeda Site 15
Yodogawa-ku, Osaka-shi, Osaka 532-0003
Japan
Takeda Site 16
Shinjuku-ku, Tokyo 162-0851
Japan
Takeda Site 11
Barcelona, 8036
Spain
Takeda Site 10
Madrid, 28043
Spain