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

NCT ID NCT05816382

Recruiting now Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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Study contacts

Contact

Phone: •••-•••-•••• 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