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New drug TAK-360 tested for Long-Term safety in sleep disorders

NCT ID NCT07646678

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 8 times

Summary

This study looks at the long-term safety and tolerability of the drug TAK-360 in people with narcolepsy (type 1 or 2) or idiopathic hypersomnia — conditions that cause severe daytime sleepiness. Participants who completed a previous TAK-360 study can join and will continue taking the drug. The main goal is to see how well people tolerate TAK-360 over many months and to track any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-360
What this could lead to
If successful, this could confirm that TAK-360 is safe enough to use long-term for managing excessive daytime sleepiness in narcolepsy and idiopathic hypersomnia.
What could go wrong
This is an extension study focused on safety, not on proving how well the drug works. It may not show clear benefits, and side effects could emerge over longer use.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 500 people

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

Started

Jun 2026

Expected to finish

Jun 2031

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 71 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. Participant is willing and able to understand and fully comply with trial procedures and requirements. 2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial. 3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures. Key Exclusion Criteria: 1. Participant has a positive pregnancy test or is lactating/breastfeeding. 2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS). 3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS). 4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs. 5. Participant has developed a new history of seizures. 6. Participant has experienced clinically significant head injury, per investigator opinion. 7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \[\<\] 5 years ago), or cerebral haemorrhage. 8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure. 9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder. 10. Participant has developed a history of cancer in the past 5 years.

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Conditions

The condition(s) this trial relates to.

idiopathic hypersomnia narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

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

Idiopathic hypersomnia Narcolepsy type 1 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

    24 sites in 5 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

    Shinjuku-ku, Tokyo, 162-0851, Japan

  • Takeda Site 10

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Takeda Site 11

    RECRUITING

    Brandon, Florida, 33511, United States

  • Takeda Site 12

    RECRUITING

    Xicheng, Beijing Municipality, 100053, China

  • Takeda Site 13

    RECRUITING

    Kumamoto, Kumamoto, 162-0851, Japan

  • Takeda Site 14

    RECRUITING

    Colorado Springs, Colorado, 80918, United States

  • Takeda Site 15

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Takeda Site 16

    RECRUITING

    Zhenzhou, Henan, 450003, China

  • Takeda Site 17

    RECRUITING

    Daegu, Daegu Gwang'yeogsi, 42601, South Korea

  • Takeda Site 18

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Takeda Site 19

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Takeda Site 2

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Takeda Site 20

    RECRUITING

    Austin, Texas, 78731, United States

  • Takeda Site 21

    RECRUITING

    Southfield, Michigan, 48075, United States

  • Takeda Site 22

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Takeda Site 23

    RECRUITING

    Chula Vista, California, 91910, United States

  • Takeda Site 24

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Takeda Site 3

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Takeda Site 4

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Takeda Site 5

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Takeda Site 6

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Takeda Site 7

    RECRUITING

    Miami, Florida, 33176, United States

  • Takeda Site 8

    RECRUITING

    Columbia, South Carolina, 29021, United States

  • Takeda Site 9

    RECRUITING

    St Louis, Missouri, 63123, United States

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