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A Study of TAK-861 in People With Narcolepsy Type 1
Sponsor: Takeda
Summary
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2024-10-08
Completion Date
2025-06-04
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
TAK-861
Oral tablet.
Placebo
TAK-861-matching placebo tablet.
Locations (28)
Takeda Site 1
Glebe, New South Wales, Australia
Takeda Site 22
Linz, Austria
Takeda Site 2
Alken, Belgium
Takeda Site 3
Erpent, Belgium
Takeda Site 25
Ghent, Belgium
Takeda Site 24
Leuven, Belgium
Takeda Site 23
Liège, Belgium
Takeda Site 4
Beijing, Beijing Municipality, China
Takeda Site 27
Zhengzhou, Henan, China
Takeda Site 28
Shanghai, Shanghai Municipality, China
Takeda Site 26
Guangdong, China
Takeda Site 20
Helsinki, Finland
Takeda Site 21
Tampere, Finland
Takeda Site 16
Léon, Bordeaux, France
Takeda Site 6
Bron, France
Takeda Site 14
Marseille, France
Takeda Site 5
Montpellier, France
Takeda Site 15
Nantes, France
Takeda Site 7
Bologna, Italy
Takeda Site 17
Pozzilli, Italy
Takeda Site 8
Roma, Italy
Takeda Site 9
Krakow, Poland
Takeda Site 11
Seoul, Daegu, South Korea
Takeda Site 10
Suwon, Gyeonggi-do, South Korea
Takeda Site 12
Seoul, South Korea
28003
Barcelona, Spain
Takeda Site 13
Madrid, Spain
Takeda Site 19
Uppsala, Sweden