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New narcolepsy drug TAK-861 put to the test in withdrawal trial

NCT ID NCT07363720

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Updated 4 times

Summary

This study tests whether TAK-861 can control symptoms of narcolepsy type 1, a condition causing sudden sleep attacks and muscle weakness. About 88 adults will take TAK-861 for several months, then some will switch to a placebo to see if symptoms return. The goal is to see if the drug's effect lasts and is better than no treatment.

What this could mean

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

Active substance
TAK-861
What this could lead to
If it works, this could provide a new treatment option to control excessive daytime sleepiness and sudden muscle weakness in people with narcolepsy type 1.
What could go wrong
This is a small Phase 3 trial with only 88 participants, and the main test is a short 4-week withdrawal period. The drug may not prove better than placebo, and long-term safety is not yet established.

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

98 people

The number who actually took part.

Started

Jan 2026

Expected to finish

Oct 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

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 square meter (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 is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1\*06:02) or results from radioimmunoassay indicate the participant's CSF OX/hypocretin-1 concentration is ≤110 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 (except for a single febrile seizure in childhood). 7. The participant has a history of cerebral ischemia, transient ischemic attack (less than 5 years from screening), intracranial aneurysm, or arteriovenous malformation.

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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 (NT1) Narcolepsy with cataplexy

Contacts and locations

Locations

  • Takeda Site 1

    Montpellier, 34295, France

  • Takeda Site 10

    Barcelona, 08036, Spain

  • Takeda Site 11

    Alzira, Valencia, 46600, Spain

  • Takeda Site 12

    Vitoria-Gasteiz, Alava, 01004, Spain

  • Takeda Site 13

    Barmelweid, Canton of Aargau, 5017, Switzerland

  • Takeda Site 14

    Bern, 3010, Switzerland

  • Takeda Site 15

    Redwood City, California, 94063, United States

  • Takeda Site 16

    Cincinnati, Ohio, 45245, United States

  • Takeda Site 17

    Columbia, South Carolina, 29201, United States

  • Takeda Site 18

    Cleveland, Ohio, 44195, United States

  • Takeda Site 19

    Brandon, Florida, 33511, United States

  • Takeda Site 2

    Paris, 75013, France

  • Takeda Site 20

    Middletown, New Jersey, 07748, United States

  • Takeda Site 21

    Austin, Texas, 78731, United States

  • Takeda Site 22

    Miami, Florida, 33155, United States

  • Takeda Site 23

    Southfield, Michigan, 48075, United States

  • Takeda Site 24

    Durham, North Carolina, 27710-4000, United States

  • Takeda Site 25

    Winston-Salem, North Carolina, 27103, United States

  • Takeda Site 3

    Toulouse, 31059, France

  • Takeda Site 4

    Schwerin, Mecklenburg-Vorpommern, 19053, Germany

  • Takeda Site 5

    Berlin, 10117, Germany

  • Takeda Site 6

    Bologna, Emilia-Romagna, 40139, Italy

  • Takeda Site 7

    Rome, Lazio, 00133, Italy

  • Takeda Site 8

    Heemstede, 2103 SW, Netherlands

  • Takeda Site 9

    Madrid, 28043, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.