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New pill mimics brain chemical to fight daytime sleepiness

NCT ID NCT06952699

Symptom relief Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This study tests a new drug called TAK-360 for people with narcolepsy type 2, a condition that causes severe daytime sleepiness. The drug acts like a natural brain chemical (orexin) that helps keep people awake. About 88 adults will receive either TAK-360 or a placebo to see if the drug is safe and can improve alertness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

narcolepsy without cataplexy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Narcolepsy type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    48 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Takeda Site 1

    RECRUITING

    Colorado Springs, Colorado, 80918-3408, United States

  • Takeda Site 10

    RECRUITING

    Santa Ana, California, 92705-8519, United States

  • Takeda Site 11

    RECRUITING

    Norfolk, Virginia, 23510-1021, United States

  • Takeda Site 12

    RECRUITING

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

  • Takeda Site 13

    RECRUITING

    Brandon, Florida, 33511-5719, United States

  • Takeda Site 14

    RECRUITING

    Redwood City, California, 94063-3132, United States

  • Takeda Site 15

    RECRUITING

    Paris, 75013, France

  • Takeda Site 16

    RECRUITING

    Junggu, Daegu Gwang'yeogsi, South Korea

  • Takeda Site 17

    WITHDRAWN

    Montpellier, Hérault, 34090, France

  • Takeda Site 18

    RECRUITING

    Madrid, 28046, Spain

  • Takeda Site 19

    RECRUITING

    Suwon, Gyeonggido, 16247, South Korea

  • Takeda Site 2

    RECRUITING

    Columbia, South Carolina, 29201-2923, United States

  • Takeda Site 20

    RECRUITING

    Shinjuku-ku, Tokyo, 162-0851, Japan

  • Takeda Site 21

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Takeda Site 22

    RECRUITING

    Rome, Lazio, 133, Italy

  • Takeda Site 23

    RECRUITING

    Bologna, 40139, Italy

  • Takeda Site 24

    RECRUITING

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

  • Takeda Site 26

    RECRUITING

    Sumida-Ku, Tokyo, 130-0004, Japan

  • Takeda Site 27

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Takeda Site 28

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

  • Takeda Site 29

    RECRUITING

    Guangzhou, Guangzhou, 510515, China

  • Takeda Site 3

    RECRUITING

    Orlando, Florida, 32803-1468, United States

  • Takeda Site 30

    RECRUITING

    Urasoe-Shi, Okinawa, 901-2132, Japan

  • Takeda Site 31

    RECRUITING

    Verona, Veneto, 37134, Italy

  • Takeda Site 32

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Takeda Site 33

    RECRUITING

    Orlando, Florida, 32807, United States

  • Takeda Site 34

    RECRUITING

    Lathrup Village, Michigan, 48076, United States

  • Takeda Site 35

    RECRUITING

    Miami, Florida, 33176, United States

  • Takeda Site 36

    RECRUITING

    Auburn, Alabama, 36832, United States

  • Takeda Site 37

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Takeda Site 38

    RECRUITING

    Austin, Texas, 78731, United States

  • Takeda Site 39

    WITHDRAWN

    Chandler, Arizona, 85224, United States

  • Takeda Site 4

    RECRUITING

    St Louis, Missouri, 63123-6968, United States

  • Takeda Site 40

    RECRUITING

    Chula Vista, California, 91910, United States

  • Takeda Site 41

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Takeda Site 42

    RECRUITING

    El Paso, Texas, 79912, United States

  • Takeda Site 43

    WITHDRAWN

    Dallas, Texas, 75235, United States

  • Takeda Site 44

    RECRUITING

    Miami, Florida, 33155, United States

  • Takeda Site 45

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Takeda Site 46

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • Takeda Site 47

    WITHDRAWN

    Mansfield, Texas, 76063, United States

  • Takeda Site 48

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Takeda Site 49

    RECRUITING

    Bowie, Maryland, 20715, United States

  • Takeda Site 5

    RECRUITING

    Cincinnati, Ohio, 45245-4500, United States

  • Takeda Site 50

    RECRUITING

    Lansing, Michigan, 48911, United States

  • Takeda Site 51

    RECRUITING

    Changchun, Jilin, 130021, China

  • Takeda Site 52

    RECRUITING

    Fukuoka, 812-0025, Japan

  • Takeda Site 53

    RECRUITING

    Isahaya-shi, Nagasaki, 854-0081, Japan

  • Takeda Site 6

    RECRUITING

    Huntersville, North Carolina, 28078-5082, United States

  • Takeda Site 7

    RECRUITING

    San Antonio, Texas, 78229-4849, United States

  • Takeda Site 8

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Takeda Site 9

    RECRUITING

    Kumamoto, Kumamoto, 862-0954, Japan

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