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COMPLETED
NCT06505031
PHASE3

A Study of TAK-861 in People With Narcolepsy Type 1

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

The main aim of this study is to learn how effective TAK-861 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 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 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.

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

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2024-10-08

Completion Date

2025-06-04

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

DRUG

TAK-861

Oral tablet.

DRUG

Placebo

TAK-861-matching placebo tablet.

Locations (28)

Takeda Site 1

Glebe, New South Wales, Australia

Takeda Site 22

Linz, Austria

Takeda Site 2

Alken, Belgium

Takeda Site 3

Erpent, Belgium

Takeda Site 25

Ghent, Belgium

Takeda Site 24

Leuven, Belgium

Takeda Site 23

Liège, Belgium

Takeda Site 4

Beijing, Beijing Municipality, China

Takeda Site 27

Zhengzhou, Henan, China

Takeda Site 28

Shanghai, Shanghai Municipality, China

Takeda Site 26

Guangdong, China

Takeda Site 20

Helsinki, Finland

Takeda Site 21

Tampere, Finland

Takeda Site 16

Léon, Bordeaux, France

Takeda Site 6

Bron, France

Takeda Site 14

Marseille, France

Takeda Site 5

Montpellier, France

Takeda Site 15

Nantes, France

Takeda Site 7

Bologna, Italy

Takeda Site 17

Pozzilli, Italy

Takeda Site 8

Roma, Italy

Takeda Site 9

Krakow, Poland

Takeda Site 11

Seoul, Daegu, South Korea

Takeda Site 10

Suwon, Gyeonggi-do, South Korea

Takeda Site 12

Seoul, South Korea

28003

Barcelona, Spain

Takeda Site 13

Madrid, Spain

Takeda Site 19

Uppsala, Sweden