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New pill aims to keep narcolepsy patients awake and steady

NCT ID NCT06505031

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tested an experimental drug called TAK-861 in 105 adults with narcolepsy type 1, a condition causing severe daytime sleepiness and sudden muscle weakness (cataplexy). Participants took either TAK-861 or a placebo daily for 3 months. The main goal was to see if the drug helps people stay awake during the day and reduces cataplexy attacks. Researchers also checked safety and quality of life.

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 (oral tablet)
What this could lead to
If successful, TAK-861 could offer a new treatment option to reduce daytime sleepiness and sudden muscle weakness attacks in people with narcolepsy type 1.
What could go wrong
This is a completed Phase 3 trial with only 105 participants, so results may not apply to everyone. The drug may cause side effects and might not work better than placebo.

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

105 people

The number who actually took part.

Started

Oct 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

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.

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 any current unstable psychiatric disorder or current active major depressive episode (MDE) or an active MDE in the past 6 months.

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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

  • 28003

    Barcelona, 08035, Spain

  • Takeda Site 1

    Glebe, New South Wales, Australia

  • Takeda Site 10

    Suwon, Gyeonggi-do, 16247, South Korea

  • Takeda Site 11

    Seoul, Daegu, 41931, South Korea

  • Takeda Site 12

    Seoul, 3080, South Korea

  • Takeda Site 13

    Madrid, Spain

  • Takeda Site 14

    Marseille, 13385, France

  • Takeda Site 15

    Nantes, 44093, France

  • Takeda Site 16

    Léon, Bordeaux, 33076, France

  • Takeda Site 17

    Pozzilli, 86077, Italy

  • Takeda Site 19

    Uppsala, Sweden

  • Takeda Site 2

    Alken, Belgium

  • Takeda Site 20

    Helsinki, 380, Finland

  • Takeda Site 21

    Tampere, 33520, Finland

  • Takeda Site 22

    Linz, 4020, Austria

  • Takeda Site 23

    Liège, 4000, Belgium

  • Takeda Site 24

    Leuven, 3000, Belgium

  • Takeda Site 25

    Ghent, 9000, Belgium

  • Takeda Site 26

    Guangdong, China

  • Takeda Site 27

    Zhengzhou, Henan, China

  • Takeda Site 28

    Shanghai, Shanghai Municipality, China

  • Takeda Site 3

    Erpent, 5101, Belgium

  • Takeda Site 4

    Beijing, Beijing Municipality, China

  • Takeda Site 5

    Montpellier, France

  • Takeda Site 6

    Bron, France

  • Takeda Site 7

    Bologna, 40139, Italy

  • Takeda Site 8

    Roma, Italy

  • Takeda Site 9

    Krakow, Poland

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