TAK-360 for Narcolepsy with Cataplexy
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with Narcolepsy Type 1 (with cataplexy) who have a body mass index between 18 and 40. Participants must stop their current narcolepsy medications before starting the study.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- TAK-360
Trial Overview
The study tests TAK-360, a new treatment for Narcolepsy Type 1, compared to a placebo. Adults are randomly assigned to receive either TAK-360 or placebo, and will be monitored during and after treatment.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive TAK-360 tablets, orally.
Participants will receive TAK-360 tablets, orally.
Participants will receive TAK-360 tablets, orally.
Participants will receive TAK-360 matching placebo tablets, orally.
Participants will receive TAK-360 matching placebo tablets, orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
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