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

Last updated: March 18, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

3

Condition

Narcolepsy

Treatment

TAK-861

Placebo

Clinical Study ID

NCT06470828
TAK-861-3001
jRCT2051240083
EU CTIS
2023-508465-32-00
  • Ages 16-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms permeter square (kg/m^2).

  2. The participant has an International Classification of Sleep Disorders, ThirdEdition (ICSD-3) or International Classification of Sleep Disorders, Third Edition,Text Revision (ICSD-3-TR) diagnosis of NT1.

  3. The participant has greater than or equal to (≥)4 partial or complete episodes ofcataplexy/week (WCR).

  4. The participant is positive for the human leukocyte antigen (HLA) genotypeHLA-DQB1*06:02 or results from radioimmunoassay indicate the participant'scerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than orequal to (≤)110 picograms per milliliter (pg/mL) [or less than one-third of the meanvalues obtained in normal participants within the same standardized assay].

Exclusion

Exclusion Criteria:

  1. The participant has a current medical disorder, other than narcolepsy withcataplexy, associated with EDS.

  2. The participant: (a) has a history of myocardial infarction; (b) has a history ofclinically significant hepatic disease, thyroid disease, coronary artery disease,cardiac rhythm abnormality or heart failure; or (c) has any medical condition (suchas unstable cardiovascular, pulmonary, renal or gastrointestinal disease).

  3. The participant has current or recent (within 6 months) gastrointestinal diseasethat is expected to influence the absorption of drugs.

  4. The participant has a history of cancer in the past 5 years.

  5. The participant has a clinically significant history of head injury or head trauma.

  6. The participant has a history of epilepsy, seizure, or convulsion.

  7. The participant has a history of cerebral ischemia, transient ischemic attack (<5years from screening), intracranial aneurysm, or arteriovenous malformation.

Study Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: TAK-861
Phase: 3
Study Start date:
July 02, 2024
Estimated Completion Date:
June 30, 2025

Study Description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 (NT1).

The study will enroll approximately 152 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups:

  1. TAK-861 Dose 1

  2. TAK-861 Dose 2

  3. Placebo

The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.

Connect with a study center

  • Takeda Site 21

    Ottawa, Ontario K2A 3Z3
    Canada

    Site Not Available

  • Takeda Site 11

    Toronto, Ontario M5S 3A3
    Canada

    Site Not Available

  • Takeda Site 50

    Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Takeda Site 25

    Montpellier, Herault 34090
    France

    Site Not Available

  • Takeda Site 43

    Toulouse, Midi-Pyrenees 31059
    France

    Site Not Available

  • Takeda Site 40

    Lyon, 69004
    France

    Site Not Available

  • Takeda Site 29

    Paris, 75013
    France

    Site Not Available

  • Takeda Site 47

    Regensberg, Bayern 93053
    Germany

    Site Not Available

  • Takeda Site 34

    Berlin, 10117
    Germany

    Site Not Available

  • Takeda Site 26

    Schwerin, 19053
    Germany

    Site Not Available

  • Takeda Site 32

    Roma, Lazio OO133
    Italy

    Site Not Available

  • Takeda Site 30

    Bologna, 40139
    Italy

    Site Not Available

  • Takeda Site 16

    Kurume-shi, Fukuka-Ken 830-0011
    Japan

    Site Not Available

  • Takeda Site 13

    Kitakyushu-shi, Fukuoka 802-0084
    Japan

    Site Not Available

  • Takeda Site 14

    Fukuoka, Fukuoka-Shi Hakata-Ku 812-0025
    Japan

    Site Not Available

  • Takeda Site 9

    Kohoku, Kanagawa 222-0033
    Japan

    Site Not Available

  • Takeda Site 7

    Kumamoto-shi, Kumamoto-Ken 861-0954
    Japan

    Site Not Available

  • Takeda Site 17

    Isahaya-shi, Nagasaki-Ken 854-0081
    Japan

    Site Not Available

  • Takeda Site 15

    Urasoe-Shi, Okinawa 901-2132
    Japan

    Site Not Available

  • Takeda Site 12

    Yodogawa, Osaka 532-0003
    Japan

    Site Not Available

  • Takeda Site 8

    Bunkyo-ku, Tokyo 112-0012
    Japan

    Site Not Available

  • Takeda Site 19

    Kodaira-shi, Tokyo 187-8551
    Japan

    Site Not Available

  • Takeda Site 20

    Shibuya-ku, Tokyo 151-0053
    Japan

    Site Not Available

  • Takeda Site 28

    Zwolle,
    Netherlands

    Site Not Available

  • Takeda Site 27

    Bergen, Hordaland 5021
    Norway

    Site Not Available

  • Takeda Site 33

    Oslo, 450
    Norway

    Site Not Available

  • Takeda Site 37

    Vitoria, Alava 1004
    Spain

    Site Not Available

  • Takeda Site 38

    Castello de la Plana, Castellon 12004
    Spain

    Site Not Available

  • Takeda Site 35

    Barcelona, 8035
    Spain

    Site Not Available

  • Takeda Site 36

    Barcelona, O8036
    Spain

    Site Not Available

  • Takeda Site 24

    Madrid, 28046
    Spain

    Site Not Available

  • Takeda Site 41

    Valencia, 46600
    Spain

    Site Not Available

  • Takeda Site 22

    Barmelweid, Aargau 5017
    Switzerland

    Site Not Available

  • Takeda Site 23

    Bern, 3010
    Switzerland

    Site Not Available

  • Takeda Site 51

    Lugano, CH-6900
    Switzerland

    Site Not Available

  • Takeda Site 46

    Cambridge, CB2 OAY
    United Kingdom

    Site Not Available

  • Takeda Site 52

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Takeda Site 53

    London, W1G 9ST
    United Kingdom

    Site Not Available

  • Takeda Site 48

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Takeda Site 39

    Redwood City, California 94063
    United States

    Site Not Available

  • Takeda Site 31

    Santa Ana, California 92705
    United States

    Site Not Available

  • Takeda Site 18

    Upland, California 91786
    United States

    Site Not Available

  • Takeda Site 4

    Orlando, Florida 32803
    United States

    Site Not Available

  • Takeda Site 3

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Takeda Site 45

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Takeda Site 5

    Saint Louis, Missouri 63123
    United States

    Site Not Available

  • Takeda Site 2

    Denver, North Carolina 28037
    United States

    Site Not Available

  • Takeda Site 6

    Cincinnati, Ohio 45227
    United States

    Site Not Available

  • Takeda Site 42

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Takeda Site 49

    Danville, Pennsylvania 17821
    United States

    Site Not Available

  • Takeda Site 1

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Takeda Site 44

    Dallas, Texas 75231
    United States

    Site Not Available

  • Takeda Site 10

    Norfolk, Virginia 23510
    United States

    Site Not Available

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