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Can a new pill tame Narcolepsy's sudden sleep and muscle weakness?

NCT ID NCT06470828

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests an experimental oral drug, TAK-861, in people with narcolepsy type 1, a condition that causes severe daytime sleepiness and sudden muscle weakness (cataplexy). Researchers will compare TAK-861 against a placebo to see if it improves alertness and reduces cataplexy attacks after 12 weeks. The study also checks safety and effects on attention, quality of life, and daily functioning. About 168 adults with the condition will take part.

What this could mean

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

Active substance
an experimental oral drug called TAK-861 (oveporexton)
What this could lead to
If it works, TAK-861 could offer a new way to manage narcolepsy type 1, helping people stay awake during the day and reducing sudden muscle weakness attacks.
What could go wrong
This is a Phase 3 trial, but success is not guaranteed. The drug may not outperform placebo, and side effects are possible. Results will need confirmation before any treatment becomes available.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

168 people

The number who actually took part.

Started

Jul 2024

Finished

Jun 2025

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

16 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.

Inclusion Criteria: 1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m\^2). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1. 3. The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR). 4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) \[or less than one-third of the mean values obtained in normal participants within the same standardized assay\]. Exclusion Criteria: 1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS. 2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease). 3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs. 4. The participant has a history of cancer in the past 5 years. 5. The participant has a clinically significant history of head injury or head trauma. 6. The participant has a history of epilepsy, seizure, or convulsion. 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-cataplexy syndrome

As listed by the trial registrant

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

Narcolepsy type 1

Contacts and locations

Locations

  • Takeda Site 1

    Columbia, South Carolina, 29201, United States

  • Takeda Site 10

    Norfolk, Virginia, 23510, United States

  • Takeda Site 11

    Toronto, Ontario, M5S 3A3, Canada

  • Takeda Site 12

    Yodogawa, Osaka, 532-0003, Japan

  • Takeda Site 13

    Kitakyushu-shi, Fukuoka, 802-0084, Japan

  • Takeda Site 14

    Fukuoka, Fukuoka-Shi Hakata-Ku, 812-0025, Japan

  • Takeda Site 15

    Urasoe-Shi, Okinawa, 901-2132, Japan

  • Takeda Site 16

    Kurume-shi, Fukuka-Ken, 830-0011, Japan

  • Takeda Site 17

    Isahaya-shi, Nagasaki, 854-0081, Japan

  • Takeda Site 18

    Upland, California, 91786, United States

  • Takeda Site 19

    Kodaira-shi, Tokyo, 187-8551, Japan

  • Takeda Site 2

    Denver, North Carolina, 28037, United States

  • Takeda Site 20

    Shibuya-ku, Tokyo, 151-0053, Japan

  • Takeda Site 21

    Ottawa, Ontario, K2A 3Z3, Canada

  • Takeda Site 22

    Barmelweid, Canton of Aargau, 5017, Switzerland

  • Takeda Site 23

    Bern, 3010, Switzerland

  • Takeda Site 24

    Madrid, 28046, Spain

  • Takeda Site 25

    Montpellier, Herault, 34090, France

  • Takeda Site 26

    Schwerin, 19053, Germany

  • Takeda Site 27

    Bergen, Hordaland, 5021, Norway

  • Takeda Site 28

    Zwolle, Netherlands

  • Takeda Site 29

    Paris, 75013, France

  • Takeda Site 3

    Atlanta, Georgia, 30328, United States

  • Takeda Site 30

    Bologna, 40139, Italy

  • Takeda Site 31

    Santa Ana, California, 92705, United States

  • Takeda Site 32

    Rome, Lazio, OO133, Italy

  • Takeda Site 33

    Oslo, 450, Norway

  • Takeda Site 34

    Berlin, 10117, Germany

  • Takeda Site 35

    Barcelona, 8035, Spain

  • Takeda Site 36

    Barcelona, O8036, Spain

  • Takeda Site 37

    Vitoria-Gasteiz, Alava, 1004, Spain

  • Takeda Site 38

    Castellon, Castellon, 12004, Spain

  • Takeda Site 39

    Redwood City, California, 94063, United States

  • Takeda Site 4

    Orlando, Florida, 32803, United States

  • Takeda Site 40

    Lyon, 69004, France

  • Takeda Site 41

    Valencia, 46600, Spain

  • Takeda Site 42

    Cleveland, Ohio, 44195, United States

  • Takeda Site 43

    Toulouse, Midi-Pyrenees, 31059, France

  • Takeda Site 44

    Dallas, Texas, 75231, United States

  • Takeda Site 45

    Boston, Massachusetts, 02115, United States

  • Takeda Site 46

    Cambridge, CB2 OAY, United Kingdom

  • Takeda Site 47

    Regensberg, Bavaria, 93053, Germany

  • Takeda Site 48

    Phoenix, Arizona, 85054, United States

  • Takeda Site 49

    Danville, Pennsylvania, 17821, United States

  • Takeda Site 5

    St Louis, Missouri, 63123, United States

  • Takeda Site 50

    Montreal, Quebec, H4J 1C5, Canada

  • Takeda Site 51

    Lugano, CH-6900, Switzerland

  • Takeda Site 52

    London, SE1 9RT, United Kingdom

  • Takeda Site 53

    London, W1G 9ST, United Kingdom

  • Takeda Site 6

    Cincinnati, Ohio, 45227, United States

  • Takeda Site 7

    Kumamoto, Kumamoto, 861-0954, Japan

  • Takeda Site 8

    Bunkyo-ku, Tokyo, 112-0012, Japan

  • Takeda Site 9

    Kohoku, Kanagawa, 222-0033, Japan

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