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A Study of TAK-861 for the Treatment of Narcolepsy Type 1

Researching TAK-861 as a potential treatment for Narcolepsy Type 1.

Recruiting
16-70 years
All
Phase 3

This study tests a drug called TAK-861 for people with narcolepsy type 1 (NT1), a condition that causes daytime sleepiness and muscle weakness (cataplexy). The goal is to see if TAK-861 reduces sleepiness and cataplexy, and if it improves attention and quality of life. About 152 people will join and will be randomly put into one of three groups: two different doses of TAK-861 or a placebo (a pill with no medicine). The study will last for 12 weeks (about 3 months) and will be conducted in different places worldwide.

To join, you must be between a body mass index (BMI) of 18 and 40 and have NT1 diagnosed by a doctor. You need to have at least four episodes of cataplexy per week. Some medical conditions might prevent you from joining, like having a history of heart disease or cancer in the last 5 years.

  • Study lasts 12 weeks with different doses or placebo.
  • Participants should have NT1 and frequent cataplexy episodes.
  • Excludes those with recent serious health conditions.
Study details
    Narcolepsy Type 1

NCT06470828

Takeda

9 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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