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COMPLETED
NCT06470828
PHASE3

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

Sponsor: Takeda

View on ClinicalTrials.gov

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

Interventions

DRUG

Oveporexton

Oral tablet.

DRUG

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