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RECRUITING
NCT07363720
PHASE3

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

Sponsor: Takeda

View on ClinicalTrials.gov

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

DRUG

TAK-861

TAK-861 tablets

DRUG

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