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NCT07633301PHASE2Recruiting

A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)

Takeda

Start Date

6/4/2026

Completion Date

11/28/2027

Summary

Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy). The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends. The participants will have to visit the clinic multiple times during this study.

Eligibility Criteria

Age Range: 18 years to 70 years

Key Inclusion Criteria: 1. The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1. Key Exclusion Criteria: 1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness. 2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure. 3. The participant has a clinically significant history of head injury or head trauma. 4. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood). 5. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation. 6. The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the medical monitor). 7. The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening. 8. The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004. 9. The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.

Interventions

DRUG

TAK-360

DRUG

Placebo

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Conditions

Narcolepsy Type 1

Locations

Takeda Site 12

Redwood City, California 94063

United States

Takeda Site 14

Miami, Florida 33176

United States

Takeda Site 13

Cincinnati, Ohio 45245

United States

Takeda Site 2

Macquarie Park, New South Wales 2113

Australia

Takeda Site 4

Beijing, Beijing Municipality 100053

China

Takeda Site 3

Guangzhou, Guangdong 510515

China

Takeda Site 5

Zhengzhou, Henan 450003

China

Takeda Site 6

Herault, Montpelier 34000

France

Takeda Site 7

Paris, 75013

France

Takeda Site 8

Bologna, Emilia-Romagna 40139

Italy

Takeda Site 9

Verona, Veneto 37134

Italy

Takeda Site 17

Fukuoka, Fukuoka 812-0025

Japan

Takeda Site 1

Kumamoto, Kumamoto 862-0954

Japan

Takeda Site 18

Isahaya-shi, Nagasaki 854-0081

Japan

Takeda Site 15

Yodogawa-ku, Osaka-shi, Osaka 532-0003

Japan

Takeda Site 16

Shinjuku-ku, Tokyo 162-0851

Japan

Takeda Site 11

Barcelona, 8036

Spain

Takeda Site 10

Madrid, 28043

Spain