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

Last updated: March 13, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

3

Condition

Narcolepsy

Treatment

TAK-861

Placebo

Clinical Study ID

NCT06505031
TAK-861-3002
2024-511998-30
2024-511998-30-00
  • 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 any current unstable psychiatric disorder or current activemajor depressive episode (MDE) or an active MDE in the past 6 months.

Study Design

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: TAK-861
Phase: 3
Study Start date:
November 07, 2024
Estimated Completion Date:
July 03, 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 participants with narcolepsy with cataplexy (narcolepsy type 1 [NT1]).

The study will enroll approximately 93 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

  1. TAK-861

  2. 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 1

    Glebe, New South Wales
    Australia

    Site Not Available

  • Takeda Site 22

    Linz, 4020
    Austria

    Site Not Available

  • Takeda Site 2

    Alken,
    Belgium

    Site Not Available

  • Takeda Site 3

    Erpent, 5101
    Belgium

    Site Not Available

  • Takeda Site 25

    Ghent, 9000
    Belgium

    Site Not Available

  • Takeda Site 24

    Leuven, 3000
    Belgium

    Site Not Available

  • Takeda Site 23

    Liege, 4000
    Belgium

    Site Not Available

  • Takeda Site 4

    Beijing, Beijing
    China

    Site Not Available

  • Takeda Site 27

    Zhengzhou, Henan
    China

    Site Not Available

  • Takeda Site 28

    Shanghai, Shanghai
    China

    Site Not Available

  • Takeda Site 26

    Guangdong,
    China

    Site Not Available

  • Takeda Site 20

    Helsinki, 380
    Finland

    Site Not Available

  • Takeda Site 21

    Tampere, 33520
    Finland

    Site Not Available

  • Takeda Site 16

    Leon, Bordeaux 33076
    France

    Site Not Available

  • Takeda Site 6

    Bron,
    France

    Site Not Available

  • Takeda Site 14

    Marseille, 13385
    France

    Site Not Available

  • Takeda Site 5

    Montpellier,
    France

    Site Not Available

  • Takeda Site 15

    Nantes, 44093
    France

    Site Not Available

  • Takeda Site 6

    Paris, 75013
    France

    Site Not Available

  • Takeda Site 7

    Bologna, 40139
    Italy

    Site Not Available

  • Takeda Site 17

    Pozzilli, 86077
    Italy

    Site Not Available

  • Takeda Site 8

    Roma,
    Italy

    Site Not Available

  • Takeda Site 11

    Seoul, Daegu 41931
    Korea, Republic of

    Site Not Available

  • Takeda Site 10

    Suwon, Gyeonggi-do 16247
    Korea, Republic of

    Site Not Available

  • Takeda Site 12

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • Takeda Site 9

    Krakow,
    Poland

    Site Not Available

  • 28003

    Barcelona, 08035
    Spain

    Site Not Available

  • Takeda Site 13

    Madrid,
    Spain

    Site Not Available

  • Takeda Site 19

    Uppsala,
    Sweden

    Site Not Available

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