Clinical Trial

A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)

Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07633301
Lead Sponsor Takeda
Conditions Narcolepsy Type 1
Enrollment 92 participants
Start Date 2026-06-04
Primary Completion 2027-11-28 (estimated)
Study Completion 2027-11-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-09