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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

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

TAK-861

TAK-861 tablets

DRUG

Placebo

TAK-861-matching placebo tablets

Locations (7)

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 2

Cincinnati, Ohio, United States

Takeda Site 3

Columbia, South Carolina, United States

Takeda Site 5

Austin, Texas, United States