RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Takeda • ClinicalTrials.gov ID: NCT06952699

Registry updated: 2026-10-08

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Description

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.

Interventions

TAK-360 (Drug)
TAK-360 tablet.
Placebo (Other)
TAK-360 matching placebo tablet.

Eligibility criteria

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.

Conditions

Narcolepsy Type 2

Locations

Takeda Site 36 — Auburn, Alabama, United States
Takeda Site 39 — Chandler, Arizona, United States
Takeda Site 40 — Chula Vista, California, United States
Takeda Site 14 — Redwood City, California, United States
Takeda Site 10 — Santa Ana, California, United States
Takeda Site 1 — Colorado Springs, Colorado, United States
Takeda Site 48 — Bradenton, Florida, United States
Takeda Site 13 — Brandon, Florida, United States
Takeda Site 46 — Jacksonville, Florida, United States
Takeda Site 44 — Miami, Florida, United States
Takeda Site 35 — Miami, Florida, United States
Takeda Site 3 — Orlando, Florida, United States
Takeda Site 33 — Orlando, Florida, United States
Takeda Site 32 — Atlanta, Georgia, United States
Takeda Site 49 — Bowie, Maryland, United States
Takeda Site 50 — Lansing, Michigan, United States
Takeda Site 34 — Lathrup Village, Michigan, United States
Takeda Site 4 — St Louis, Missouri, United States
Takeda Site 37 — Middletown, New Jersey, United States
Takeda Site 8 — Denver, North Carolina, United States
Takeda Site 6 — Huntersville, North Carolina, United States
Takeda Site 41 — Winston-Salem, North Carolina, United States
Takeda Site 5 — Cincinnati, Ohio, United States
Takeda Site 45 — Cleveland, Ohio, United States
Takeda Site 2 — Columbia, South Carolina, United States
Takeda Site 38 — Austin, Texas, United States
Takeda Site 43 — Dallas, Texas, United States
Takeda Site 42 — El Paso, Texas, United States
Takeda Site 47 — Mansfield, Texas, United States
Takeda Site 7 — San Antonio, Texas, United States
Takeda Site 11 — Norfolk, Virginia, United States
Takeda Site 28 — Beijing, Beijing Municipality, China
Takeda Site 29 — Guangzhou, Guangzhou, China
Takeda Site 51 — Changchun, Jilin, China
Takeda Site 27 — Shanghai, Shanghai Municipality, China
Takeda Site 17 — Montpellier, Hérault, France
Takeda Site 15 — Paris, France
Takeda Site 22 — Rome, Lazio, Italy
Takeda Site 31 — Verona, Veneto, Italy
Takeda Site 23 — Bologna, Italy
Takeda Site 24 — Kohoku-ku, Yokohama-Shi, Kanagawa, Japan
Takeda Site 9 — Kumamoto, Kumamoto, Japan
Takeda Site 53 — Isahaya-shi, Nagasaki, Japan
Takeda Site 30 — Urasoe-Shi, Okinawa, Japan
Takeda Site 20 — Shinjuku-ku, Tokyo, Japan
Takeda Site 26 — Sumida-Ku, Tokyo, Japan
Takeda Site 52 — Fukuoka, Japan
Takeda Site 12 — Yodogawa-ku, Osaka-shi, Ôsaka, Japan
Takeda Site 16 — Junggu, Daegu Gwang'yeogsi, South Korea
Takeda Site 19 — Suwon, Gyeonggido, South Korea
Takeda Site 21 — Seoul, Seoul Teugbyeolsi, South Korea
Takeda Site 18 — Madrid, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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