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New narcolepsy drug TAK-861 tested for Long-Term safety

NCT ID NCT05816382

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is checking the long-term safety of a drug called TAK-861 in 500 people with type 1 narcolepsy who have already taken it in earlier trials. Participants will continue taking TAK-861 tablets, and researchers will monitor for side effects. The goal is to see if the drug remains safe over an extended period.

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 (a drug taken as a tablet)
What this could lead to
If successful, this could show that TAK-861 is safe enough for long-term use, potentially offering a new treatment option for managing narcolepsy type 1.
What could go wrong
This is an extension study, so it builds on earlier trials. The drug may still cause side effects, and it's not yet proven to work better than existing treatments. The study focuses on safety, not effectiveness.

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

Apr 2023

Expected to finish

Feb 2028

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\. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment. Exclusion criteria: 1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial. 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 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (\>) 1.5 times the upper limit of normal (ULN). 4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS). 5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months. 6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs. 7. Participant has epilepsy or history of seizure. 8. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications. 9. Participant has a history of cerebral ischemia, transient ischemic attack (less than (\<) 5 years ago), or cerebral hemorrhage. 10. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure. 11. Participant has a history of cancer in the past 5 years.

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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

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

    52 sites in 12 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

  • ARSM Research, LLC

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Aichi Medical University Hospital

    RECRUITING

    Nagakute, 480-1195, Japan

  • Bogan Sleep Consultants, LLC

    RECRUITING

    Columbia, South Carolina, 29201, United States

  • CHU Gui De Chauliac

    RECRUITING

    Montpellier, Herault, 34090, France

  • CHU de Grenoble

    RECRUITING

    La Tronche, Isere, 38700, France

  • CTI Research Center

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • Charite - Universitatsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Children's Specialty Group

    RECRUITING

    Norfolk, Virginia, 23510, United States

  • Delta Waves LLC - Hunt - PPDS

    RECRUITING

    Colorado Springs, Colorado, 80918, United States

  • Florida Pediatric Research Institute

    RECRUITING

    Orlando, Florida, 32803, United States

  • Fondazione PTV Policlinico Tor Vergata

    RECRUITING

    Rome, Lazio, 00133, Italy

  • Georgia Neuro Center

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Gokeikai Osaka Kaisei Hospital

    RECRUITING

    Osaka, Osaka, 532-0003, Japan

  • Henry Ford Medical Center - Columbus

    RECRUITING

    Novi, Michigan, 48377, United States

  • Hopital Pierre-Paul Riquet

    RECRUITING

    Toulouse, Haute-Garonne, 31000, France

  • Hopital de la Pitie Salpetriere

    RECRUITING

    Paris, 75013, France

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General de Castello

    RECRUITING

    Castellon, Castellon, 12004, Spain

  • Hospital Universitario Araba Santiago

    RECRUITING

    Vitoria-Gasteiz, Alava, 01009, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Vithas Madrid Arturo Soria

    RECRUITING

    Madrid, 28046, Spain

  • Hospital de La Ribera

    RECRUITING

    Alzira, Valencia, 46600, Spain

  • Howakai Kuwamizu Hospital

    RECRUITING

    Kumamoto, Kumamoto, 862-0954, Japan

  • Instituto de Investigaciones del Sueno

    RECRUITING

    Madrid, 28036, Spain

  • Intrepid Research

    RECRUITING

    Cincinnati, Ohio, 45227, United States

  • Istituto Neurologico Mediterraneo Neuromed

    RECRUITING

    Pozzilli, Molise, 86077, Italy

  • Kempenhaeghe - PPDS

    RECRUITING

    Heeze, North Brabant, 5591 VE, Netherlands

  • Klinik Barmelweid AG

    RECRUITING

    Barmelweid, Aargau (de), 5017, Switzerland

  • Klinische Forschung Hamburg

    RECRUITING

    Hamburg, 20253, Germany

  • Koishikawa Tokyo Hospital

    RECRUITING

    Bunkyo-Ku, Tokyo, 112-0012, Japan

  • Kurume University Hospital

    RECRUITING

    Kurume-Shi, Hukuoka, 830-0011, Japan

  • Medical University of South Carolina - PPDS

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Neurocare Inc

    RECRUITING

    Newton, Massachusetts, 02459, United States

  • Neurocenter of Southern Switzerland

    RECRUITING

    Lugano, Ticino (it), 6900, Switzerland

  • Neurotrials Research

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Ohio Sleep Medicine Institute

    RECRUITING

    Dublin, Ohio, 43017, United States

  • Ospedale Bellaria

    RECRUITING

    Bellaria, 40139, Italy

  • Research Carolina Elite

    RECRUITING

    Denver, North Carolina, 28037, United States

  • SDS Clinical Trials, Inc.

    RECRUITING

    Santa Ana, California, 92705, United States

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Västra Götaland County, 413 46, Sweden

  • Slaap-Waakcentrum SEIN Heemstede

    RECRUITING

    Heemstede, North Holland, 2103 SW, Netherlands

  • Sleep Disorders Center of Alabama

    RECRUITING

    Birmingham, Alabama, 35213, United States

  • Sleep Therapy and Research Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

    RECRUITING

    Schwerin, Mecklenburg-Vorpommern, 19053, Germany

  • Stanford Center for Sleep Sciences and Medicine

    RECRUITING

    Redwood City, California, 94063, United States

  • Terveystalo Helsinki Sleep Clinic

    RECRUITING

    Helsinki, Uusimaa, 00380, Finland

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Universitaet Regensburg am Bezirksklinikum

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • Universitaetsspital Bern - Inselspital

    RECRUITING

    Bern, 43017-3521, Switzerland

  • University of Oslo

    RECRUITING

    Oslo, 0450, Norway

  • Woolcock Institute of Medical Research

    RECRUITING

    Glebe, New South Wales, 2037, Australia

  • YOU ARIYOSHI Sleep Clinic

    RECRUITING

    Nagasaki, Nagasaki, 850-0045, Japan

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