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

NCT ID: NCT06505031

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-06-04

Brief 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.

Detailed 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.

Conditions

Narcolepsy Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TAK-861

Participants will receive TAK-861 tablets, orally, for 12 weeks.

Group Type: EXPERIMENTAL

TAK-861

Intervention Type: DRUG

Oral tablet.

Placebo

Participants will receive TAK-861-matching placebo tablets, orally, for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

TAK-861-matching placebo tablet.

Interventions

TAK-861

Oral tablet.

Intervention Type: DRUG

Placebo

TAK-861-matching placebo tablet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. The participant has an International Classification of Sleep Disorders, Third Edition (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 of cataplexy/week (WCR).

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

Exclusion Criteria

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

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

3. The participant has current or recent (within 6 months) gastrointestinal disease that 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 active major depressive episode (MDE) or an active MDE in the past 6 months.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

Countries

Australia; Austria; Belgium; China; Finland; France; Italy; Poland; South Korea; Spain; Sweden

Related Links

https://clinicaltrials.takeda.com/study-detail/7838a845d8c64357??page=1&idFilter=TAK-861-3002

To obtain more information on the study, click here/on this link.

Other Identifiers

2024-511998-30-00

Identifier Type: CTIS

Identifier Source: secondary_id

TAK-861-3002

Identifier Type: -

Identifier Source: org_study_id