A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

Recruiting Phase 3 Interventional Study
Narcolepsy Type 1 (NT1) Narcolepsy With Cataplexy
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
16 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
88 (estimated)
Sponsor
Takeda · Industry
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About This Trial
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^2). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Tex…
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