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A Study of TAK-861 for the Treatment of Narcolepsy Type 1
Sponsor: Takeda
Summary
The main aim of this study is to learn how effective TAK-861 (oveporexton) 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 (oveporexton) 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 (oveporexton) 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 (oveporexton).
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
16 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2024-07-02
Completion Date
2025-06-03
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Oveporexton
Oral tablet.
Placebo
OVE-matching placebo tablet.
Locations (53)
Takeda Site 48
Phoenix, Arizona, United States
Takeda Site 39
Redwood City, California, United States
Takeda Site 31
Santa Ana, California, United States
Takeda Site 18
Upland, California, United States
Takeda Site 4
Orlando, Florida, United States
Takeda Site 3
Atlanta, Georgia, United States
Takeda Site 45
Boston, Massachusetts, United States
Takeda Site 5
St Louis, Missouri, United States
Takeda Site 2
Denver, North Carolina, United States
Takeda Site 6
Cincinnati, Ohio, United States
Takeda Site 42
Cleveland, Ohio, United States
Takeda Site 49
Danville, Pennsylvania, United States
Takeda Site 1
Columbia, South Carolina, United States
Takeda Site 44
Dallas, Texas, United States
Takeda Site 10
Norfolk, Virginia, United States
Takeda Site 21
Ottawa, Ontario, Canada
Takeda Site 11
Toronto, Ontario, Canada
Takeda Site 50
Montreal, Quebec, Canada
Takeda Site 25
Montpellier, Herault, France
Takeda Site 43
Toulouse, Midi-Pyrenees, France
Takeda Site 40
Lyon, France
Takeda Site 29
Paris, France
Takeda Site 47
Regensberg, Bavaria, Germany
Takeda Site 34
Berlin, Germany
Takeda Site 26
Schwerin, Germany
Takeda Site 32
Rome, Lazio, Italy
Takeda Site 30
Bologna, Italy
Takeda Site 16
Kurume-shi, Fukuka-Ken, Japan
Takeda Site 13
Kitakyushu-shi, Fukuoka, Japan
Takeda Site 14
Fukuoka, Fukuoka-Shi Hakata-Ku, Japan
Takeda Site 9
Kohoku, Kanagawa, Japan
Takeda Site 7
Kumamoto, Kumamoto, Japan
Takeda Site 17
Isahaya-shi, Nagasaki, Japan
Takeda Site 15
Urasoe-Shi, Okinawa, Japan
Takeda Site 12
Yodogawa, Osaka, Japan
Takeda Site 8
Bunkyo-ku, Tokyo, Japan
Takeda Site 19
Kodaira-shi, Tokyo, Japan
Takeda Site 20
Shibuya-ku, Tokyo, Japan
Takeda Site 28
Zwolle, Netherlands
Takeda Site 27
Bergen, Hordaland, Norway
Takeda Site 33
Oslo, Norway
Takeda Site 37
Vitoria-Gasteiz, Alava, Spain
Takeda Site 38
Castellon, Castellon, Spain
Takeda Site 35
Barcelona, Spain
Takeda Site 36
Barcelona, Spain
Takeda Site 24
Madrid, Spain
Takeda Site 41
Valencia, Spain
Takeda Site 22
Barmelweid, Canton of Aargau, Switzerland
Takeda Site 23
Bern, Switzerland
Takeda Site 51
Lugano, Switzerland
Takeda Site 46
Cambridge, United Kingdom
Takeda Site 52
London, United Kingdom
Takeda Site 53
London, United Kingdom