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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
2026-05-08
Healthy Volunteers
No
Interventions
TAK-861
TAK-861 tablets
Placebo
TAK-861-matching placebo tablets
Locations (18)
Takeda Site 1
Redwood City, California, United States
Takeda Site 4
Brandon, Florida, United States
Takeda Site 6
Miami, Florida, United States
Takeda Site 7
Southfield, Michigan, United States
Takeda Site 16
Middletown, New Jersey, United States
Takeda Site 17
Durham, North Carolina, United States
Takeda Site 18
Winston-Salem, North Carolina, United States
Takeda Site 2
Cincinnati, Ohio, United States
Takeda Site 15
Cleveland, Ohio, United States
Takeda Site 3
Columbia, South Carolina, United States
Takeda Site 5
Austin, Texas, United States
Takeda Site 8
Montpellier, France
Takeda Site 9
Paris, France
Takeda Site 10
Toulouse, France
Takeda Site 11
Schwerin, Mecklenburg-Vorpommern, Germany
Takeda Site 12
Heemstede, Netherlands
Takeda Site 13
Barmelweid, Canton of Aargau, Switzerland
Takeda Site 14
Bern, Switzerland