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.
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…
Contacts