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NCT06952699PHASE2Recruiting

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Takeda

Start Date

5/6/2025

Completion Date

11/30/2026

Summary

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

Eligibility Criteria

Age Range: 18 years to 70 years

Key Inclusion Criteria: 1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\]. 2. The participant has a documented, current diagnosis of NT2. Key Exclusion Criteria: 1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2. 2. The participant has medically significant thyroid disease. 3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor). 4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening). 5. The participant has a clinically significant history of head injury or head trauma. 6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood). 7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Interventions

DRUG

TAK-360

OTHER

Placebo

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Conditions

Narcolepsy Type 2

Locations

Takeda Site 36

Auburn, Alabama 36832

United States

Takeda Site 39

Chandler, Arizona 85224

United States

Takeda Site 40

Chula Vista, California 91910

United States

Takeda Site 14

Redwood City, California 94063-3132

United States

Takeda Site 10

Santa Ana, California 92705-8519

United States

Takeda Site 1

Colorado Springs, Colorado 80918-3408

United States

Takeda Site 48

Bradenton, Florida 34209

United States

Takeda Site 13

Brandon, Florida 33511-5719

United States

Takeda Site 46

Jacksonville, Florida 32209

United States

Takeda Site 44

Miami, Florida 33155

United States

Takeda Site 35

Miami, Florida 33176

United States

Takeda Site 3

Orlando, Florida 32803-1468

United States

Takeda Site 33

Orlando, Florida 32807

United States

Takeda Site 32

Atlanta, Georgia 30328

United States

Takeda Site 49

Bowie, Maryland 20715

United States

Takeda Site 50

Lansing, Michigan 48911

United States

Takeda Site 34

Lathrup Village, Michigan 48076

United States

Takeda Site 4

St Louis, Missouri 63123-6968

United States

Takeda Site 37

Middletown, New Jersey 07748

United States

Takeda Site 8

Denver, North Carolina 28037

United States

Takeda Site 6

Huntersville, North Carolina 28078-5082

United States

Takeda Site 41

Winston-Salem, North Carolina 27103

United States

Takeda Site 5

Cincinnati, Ohio 45245-4500

United States

Takeda Site 45

Cleveland, Ohio 44106

United States

Takeda Site 2

Columbia, South Carolina 29201-2923

United States

Takeda Site 38

Austin, Texas 78731

United States

Takeda Site 43

Dallas, Texas 75235

United States

Takeda Site 42

El Paso, Texas 79912

United States

Takeda Site 47

Mansfield, Texas 76063

United States

Takeda Site 7

San Antonio, Texas 78229-4849

United States

Takeda Site 11

Norfolk, Virginia 23510-1021

United States

Takeda Site 28

Beijing, Beijing Municipality 100053

China

Takeda Site 29

Guangzhou, Guangzhou 510515

China

Takeda Site 51

Changchun, Jilin 130021

China

Takeda Site 27

Shanghai, Shanghai Municipality 200040

China

Takeda Site 17

Montpellier, Hérault 34090

France

Takeda Site 15

Paris, 75013

France

Takeda Site 22

Rome, Lazio 133

Italy

Takeda Site 31

Verona, Veneto 37134

Italy

Takeda Site 23

Bologna, 40139

Italy

Takeda Site 24

Kohoku-ku, Yokohama-Shi, Kanagawa 222-0033

Japan

Takeda Site 9

Kumamoto, Kumamoto 862-0954

Japan

Takeda Site 53

Isahaya-shi, Nagasaki 854-0081

Japan

Takeda Site 30

Urasoe-Shi, Okinawa 901-2132

Japan

Takeda Site 20

Shinjuku-ku, Tokyo 162-0851

Japan

Takeda Site 26

Sumida-Ku, Tokyo 130-0004

Japan

Takeda Site 52

Fukuoka, 812-0025

Japan

Takeda Site 12

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

Japan

Takeda Site 16

Junggu, Daegu Gwang'yeogsi

South Korea

Takeda Site 19

Suwon, Gyeonggido 16247

South Korea

Takeda Site 21

Seoul, Seoul Teugbyeolsi 3080

South Korea

Takeda Site 18

Madrid, 28046

Spain