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New hope for narcolepsy: TAK-360 trial seeks to tame sudden muscle weakness

NCT ID NCT07633301

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study tests a new drug, TAK-360, for adults with narcolepsy type 1, a condition causing severe daytime sleepiness and sudden muscle weakness (cataplexy). About 92 participants will receive either TAK-360 or a placebo to see if the drug is safe and well-tolerated. Participants must stop their usual narcolepsy medicines during the study.

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 92 people

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

Started

Jun 2026

Expected to finish

Nov 2027

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 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.

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Conditions

The condition(s) this trial relates to.

narcolepsy narcolepsy-cataplexy syndrome

As listed by the trial registrant

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

Narcolepsy type 1

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

    18 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

    Kumamoto, Kumamoto, 862-0954, Japan

  • Takeda Site 10

    NOT_YET_RECRUITING

    Madrid, 28043, Spain

  • Takeda Site 11

    NOT_YET_RECRUITING

    Barcelona, 8036, Spain

  • Takeda Site 12

    NOT_YET_RECRUITING

    Redwood City, California, 94063, United States

  • Takeda Site 13

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Takeda Site 14

    RECRUITING

    Miami, Florida, 33176, United States

  • Takeda Site 15

    NOT_YET_RECRUITING

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

  • Takeda Site 16

    RECRUITING

    Shinjuku-ku, Tokyo, 162-0851, Japan

  • Takeda Site 17

    RECRUITING

    Fukuoka, Fukuoka, 812-0025, Japan

  • Takeda Site 18

    RECRUITING

    Isahaya-shi, Nagasaki, 854-0081, Japan

  • Takeda Site 2

    NOT_YET_RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Takeda Site 3

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Takeda Site 4

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

  • Takeda Site 5

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Takeda Site 6

    NOT_YET_RECRUITING

    Herault, Montpelier, 34000, France

  • Takeda Site 7

    NOT_YET_RECRUITING

    Paris, 75013, France

  • Takeda Site 8

    NOT_YET_RECRUITING

    Bologna, Emilia-Romagna, 40139, Italy

  • Takeda Site 9

    NOT_YET_RECRUITING

    Verona, Veneto, 37134, Italy

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