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A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
Sponsor: Takeda
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2026-06-04
Completion Date
2027-11-28
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
TAK-360
TAK-360 tablet
Placebo
TAK-360 matching placebo tablet
Locations (1)
Takeda Site 1
Kumamoto, Kumamoto, Japan