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A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Sponsor: Takeda
Summary
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 return.
Official title: A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial 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
88
Start Date
2026-01-29
Completion Date
2026-10-02
Last Updated
2026-07-08
Healthy Volunteers
No
Interventions
TAK-861
TAK-861 tablets
Placebo
TAK-861-matching placebo tablets
Locations (25)
Takeda Site 15
Redwood City, California, United States
Takeda Site 19
Brandon, Florida, United States
Takeda Site 22
Miami, Florida, United States
Takeda Site 23
Southfield, Michigan, United States
Takeda Site 20
Middletown, New Jersey, United States
Takeda Site 24
Durham, North Carolina, United States
Takeda Site 25
Winston-Salem, North Carolina, United States
Takeda Site 16
Cincinnati, Ohio, United States
Takeda Site 18
Cleveland, Ohio, United States
Takeda Site 17
Columbia, South Carolina, United States
Takeda Site 21
Austin, Texas, United States
Takeda Site 1
Montpellier, France
Takeda Site 2
Paris, France
Takeda Site 3
Toulouse, France
Takeda Site 4
Schwerin, Mecklenburg-Vorpommern, Germany
Takeda Site 5
Berlin, Germany
Takeda Site 6
Bologna, Emilia-Romagna, Italy
Takeda Site 7
Rome, Lazio, Italy
Takeda Site 8
Heemstede, Netherlands
Takeda Site 12
Vitoria-Gasteiz, Alava, Spain
Takeda Site 11
Alzira, Valencia, Spain
Takeda Site 10
Barcelona, Spain
Takeda Site 9
Madrid, Spain
Takeda Site 13
Barmelweid, Canton of Aargau, Switzerland
Takeda Site 14
Bern, Switzerland