A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Last updated: March 3, 2026
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

2/3

Condition

Narcolepsy

Treatment

TAK-861

Clinical Study ID

NCT05816382
TAK-861-2003
U1111-1283-1888
2023-508462-15-00
2023-508462-15
2022-002965-13
jRCT2031230135
  • Ages 16-70
  • All Genders

Study Summary

The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

Eligibility Criteria

Inclusion

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

Exclusion criteria:

  1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at thetime of rollover related to the trial intervention from the parent trial ordiscontinued because of TEAEs in the parent trial.

  2. Participant has a risk of suicide according to endorsement of item 4 or 5 on theColumbia 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 withoutcataplexy, associated with excessive daytime sleepiness (EDS).

  5. Participant has current active major depressive episode (MDE) or has had an activeMDE in the past 6 months.

  6. Participant has developed (within the last 6 months) gastrointestinal disease thatis 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, heartdisease, or significant hepatic, pulmonary, or renal disease, that requires them totake 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 coronaryartery disease, clinically significant angina, clinically significant cardiac rhythmabnormality, or heart failure.

  11. Participant has a history of cancer in the past 5 years.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: TAK-861
Phase: 2/3
Study Start date:
April 05, 2023
Estimated Completion Date:
February 28, 2028

Study Description

The drug being tested in this trial is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This trial will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.

This trial was initiated in parallel with the parent phase 2 trials, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916), which included participants with NT1 and narcolepsy type 2 (NT2), respectively. This long-term extension (LTE) trial enrolled participants with both diagnoses from the two phase 2 trials. As the TAK-861-2002 trial did not meet prespecified criteria, all participants with NT2 were discontinued, and moving forward this extension study only includes participants with NT1 who previously completed a parent trial. Parent trials include all TAK-861 phase 3 trials in addition to the phase 2 trial participants from TAK-861-2001.

The trial will enroll up to 500 participants. All participants in the trial will receive TAK-861. Participants who were previously on a placebo dose will be assigned to one of the TAK-861 doses randomly.

This multi-center trial will be conducted worldwide. Study period is approximately 5 years or until the study is stopped at the sponsor's discretion, or the product is approved and launched. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health) and will have a follow-up assessment 4 weeks after the last dose of trial intervention.

Connect with a study center

  • Woolcock Institute of Medical Research

    Glebe, New South Wales 2037
    Australia

    Active - Recruiting

  • Woolcock Institute of Medical Research

    Glebe 2165450, New South Wales 2155400 2037
    Australia

    Site Not Available

  • Terveystalo Helsinki Sleep Clinic

    Helsinki, Uusimaa 00380
    Finland

    Active - Recruiting

  • Terveystalo Helsinki Sleep Clinic

    Helsinki 658225, Uusimaa 830709 00380
    Finland

    Site Not Available

  • CHRU Dijon Hopital General

    Dijon, Cote-d'Or 21079
    France

    Site Not Available

  • Hopital Pierre-Paul Riquet

    Toulouse, Haute-Garonne 31000
    France

    Active - Recruiting

  • Hopital Pierre-Paul Riquet

    Toulouse 2972315, Haute-Garonne 31000
    France

    Site Not Available

  • CHU Gui De Chauliac

    Montpellier, Herault 34090
    France

    Active - Recruiting

  • CHU Gui De Chauliac

    Montpellier 2992166, Herault 34090
    France

    Site Not Available

  • CHU de Grenoble

    La Tronche, Isere 38700
    France

    Active - Recruiting

  • CHU de Grenoble

    La Tronche 3006131, Isere 38700
    France

    Site Not Available

  • Hopital Roger Salengro

    Lille, Nord 59000
    France

    Site Not Available

  • Hopital de la Pitie Salpetriere

    Paris, 75013
    France

    Active - Recruiting

  • Hotel Dieu de Paris Hospital

    Paris, 75181
    France

    Site Not Available

  • Hopital de la Pitie Salpetriere

    Paris 2988507, 75013
    France

    Site Not Available

  • Universitaet Regensburg am Bezirksklinikum

    Regensburg, Bavaria 93053
    Germany

    Active - Recruiting

  • Universitaet Regensburg am Bezirksklinikum

    Regensburg 2849483, Bavaria 2951839 93053
    Germany

    Site Not Available

  • Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin, Mecklenburg-Vorpommern 19053
    Germany

    Active - Recruiting

  • Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin 2834282, Mecklenburg-Vorpommern 2872567 19053
    Germany

    Site Not Available

  • Universitaet Witten-Herdecke

    Witten, Nordrhein-Westfalen 58453
    Germany

    Site Not Available

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117
    Germany

    Active - Recruiting

  • Charite - Universitatsmedizin Berlin

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Klinische Forschung Hamburg

    Hamburg, 20253
    Germany

    Active - Recruiting

  • Klinische Forschung Hamburg

    Hamburg 2911298, 20253
    Germany

    Site Not Available

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Lazio 00133
    Italy

    Site Not Available

  • Fondazione PTV Policlinico Tor Vergata

    Rome, Lazio 00133
    Italy

    Active - Recruiting

  • Fondazione PTV Policlinico Tor Vergata

    Rome 3169070, Lazio 3174976 00133
    Italy

    Site Not Available

  • Ospedale San Raffaele S.r.l. - PPDS

    Milano, Lombardia 20127
    Italy

    Site Not Available

  • Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Molise 86077
    Italy

    Active - Recruiting

  • Istituto Neurologico Mediterraneo Neuromed

    Pozzilli 3170006, Molise 3173222 86077
    Italy

    Site Not Available

  • Ospedale Bellaria

    Bellaria, 40139
    Italy

    Active - Recruiting

  • Ospedale Bellaria

    Bellaria 8952367, 40139
    Italy

    Site Not Available

  • Ehime University Hospital

    Tōon, Ehime 791-0295
    Japan

    Site Not Available

  • Inoue Hospital

    Fukuoka, Hukuoka 810-0044
    Japan

    Site Not Available

  • Fukuoka Urazoe Clinic

    Kitakyushu, Hukuoka 802-0084
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume-Shi, Hukuoka 830-0011
    Japan

    Active - Recruiting

  • Howakai Kuwamizu Hospital

    Kumamoto, Kumamoto 862-0954
    Japan

    Active - Recruiting

  • Howakai Kuwamizu Hospital

    Kumamoto-Shi, Kumamoto 862-0954
    Japan

    Site Not Available

  • Howakai Kuwamizu Hospital

    Kumamoto 1858421, Kumamoto 1858419 862-0954
    Japan

    Site Not Available

  • YOU ARIYOSHI Sleep Clinic

    Nagasaki, Nagasaki 850-0045
    Japan

    Active - Recruiting

  • YOU ARIYOSHI Sleep Clinic

    Nagasaki-Shi, Nagasaki 850-0045
    Japan

    Site Not Available

  • YOU ARIYOSHI Sleep Clinic

    Nagasaki 1856177, Nagasaki 1856156 850-0045
    Japan

    Site Not Available

  • Gokeikai Osaka Kaisei Hospital

    Osaka, Osaka 532-0003
    Japan

    Active - Recruiting

  • Gokeikai Osaka Kaisei Hospital

    Osaka-Shi, Osaka 532-0003
    Japan

    Site Not Available

  • Gokeikai Osaka Kaisei Hospital

    Osaka 1853909, Osaka 1853904 532-0003
    Japan

    Site Not Available

  • Koishikawa Tokyo Hospital

    Bunkyo-Ku, Tokyo 112-0012
    Japan

    Active - Recruiting

  • Akita University Hospital

    Kodaira-Shi, Tokyo 187-0031
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo 187-8551
    Japan

    Site Not Available

  • Yoyogi Sleep Disorder Center

    Shibuya-Ku, Tokyo 151-0053
    Japan

    Site Not Available

  • Aichi Medical University Hospital

    Nagakute, 480-1195
    Japan

    Active - Recruiting

  • Aichi Medical University Hospital

    Nagakute 11611613, 480-1195
    Japan

    Site Not Available

  • RESM respiratory and sleep medical-care clinic

    Yokohama, 222-0033
    Japan

    Site Not Available

  • Kempenhaeghe - PPDS

    Heeze, North Brabant 5591 VE
    Netherlands

    Active - Recruiting

  • Kempenhaeghe - PPDS

    Heeze 2754618, North Brabant 2749990 5591 VE
    Netherlands

    Site Not Available

  • Slaap-Waakcentrum SEIN Heemstede

    Heemstede, North Holland 2103 SW
    Netherlands

    Active - Recruiting

  • Slaap-Waakcentrum SEIN Heemstede

    Heemstede 2754692, North Holland 2749879 2103 SW
    Netherlands

    Site Not Available

  • University of Oslo

    Oslo, 0450
    Norway

    Active - Recruiting

  • University of Oslo

    Oslo 3143244, 0450
    Norway

    Site Not Available

  • Hospital Universitario Araba Santiago

    Vitoria, Alava 01009
    Spain

    Site Not Available

  • Hospital Universitario Araba Santiago

    Vitoria-Gasteiz, Alava 01009
    Spain

    Active - Recruiting

  • Hospital Universitario Araba Santiago

    Vitoria-Gasteiz 3104499, Alava 01009
    Spain

    Site Not Available

  • Hospital General de Castello

    Castellon, Castellon 12004
    Spain

    Active - Recruiting

  • Hospital General de Castello

    Castellon 2519752, Castellon 12004
    Spain

    Site Not Available

  • Hospital General de Castello

    Castellón De La Plana, Castellon 12004
    Spain

    Site Not Available

  • Hospital de La Ribera

    Alzira, Valencia 46600
    Spain

    Active - Recruiting

  • Hospital de La Ribera

    Alzira 2522129, Valencia 2593113 46600
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital La Milagrosa

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Vithas Madrid Arturo Soria

    Madrid, 28046
    Spain

    Active - Recruiting

  • Instituto de Investigaciones del Sueno

    Madrid, 28036
    Spain

    Active - Recruiting

  • Hospital Vithas Madrid Arturo Soria

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • Instituto de Investigaciones del Sueno

    Madrid 3117735, 28036
    Spain

    Site Not Available

  • Sahlgrenska University Hospital

    Goteborg, Vastra Gotalands Lan 413 46
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götaland County 413 46
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg 2711537, Västra Götaland County 3337386 413 46
    Sweden

    Site Not Available

  • Klinik Barmelweid AG

    Barmelweid, Aargau (de) 5017
    Switzerland

    Active - Recruiting

  • Klinik Barmelweid AG

    Barmelweid 8469091, Aargau (de) 5017
    Switzerland

    Site Not Available

  • Neurocenter of Southern Switzerland

    Lugano, Ticino (it) 6900
    Switzerland

    Active - Recruiting

  • Neurocenter of Southern Switzerland

    Lugano 2659836, Ticino (it) 6900
    Switzerland

    Site Not Available

  • Universitaetsspital Bern - Inselspital

    Bern, 43017-3521
    Switzerland

    Active - Recruiting

  • Universitaetsspital Bern - Inselspital

    Bern 2661552, 43017-3521
    Switzerland

    Site Not Available

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama 35213
    United States

    Active - Recruiting

  • Sleep Disorders Center of Alabama

    Birmingham 4049979, Alabama 4829764 35213
    United States

    Site Not Available

  • Mayo Clinic Arizona - PPDS

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Stanford Center for Sleep Sciences and Medicine

    Redwood City, California 94063
    United States

    Active - Recruiting

  • SDS Clinical Trials, Inc.

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Stanford Center for Sleep Sciences and Medicine

    Redwood City 5386834, California 5332921 94063
    United States

    Site Not Available

  • SDS Clinical Trials, Inc.

    Santa Ana 5392900, California 5332921 92705
    United States

    Site Not Available

  • Delta Waves LLC - Hunt - PPDS

    Colorado Springs, Colorado 80918
    United States

    Active - Recruiting

  • Delta Waves LLC - Hunt - PPDS

    Colorado Springs 5417598, Colorado 5417618 80918
    United States

    Site Not Available

  • Florida Pediatric Research Institute

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Florida Pediatric Research Institute

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Neurotrials Research

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Georgia Neuro Center

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Neurotrials Research

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • Georgia Neuro Center

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Site Not Available

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Center For Sleep and Wake Disorders

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Neurocare Inc

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

  • Neurocare Inc

    Newton 4945283, Massachusetts 6254926 02459
    United States

    Site Not Available

  • Henry Ford Medical Center - Columbus

    Novi, Michigan 48377
    United States

    Active - Recruiting

  • Henry Ford Medical Center - Columbus

    Novi 5004062, Michigan 5001836 48377
    United States

    Site Not Available

  • St. Lukes Sleep Medicine and Research Center

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • University of Colorado Hospital

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Research Carolina Elite

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • ARSM Research, LLC

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Research Carolina Elite

    Denver 4463523, North Carolina 4482348 28037
    United States

    Site Not Available

  • ARSM Research, LLC

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Site Not Available

  • CTI Research Center

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • Intrepid Research

    Cincinnati, Ohio 45227
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Ohio Sleep Medicine Institute

    Dublin, Ohio 43017
    United States

    Active - Recruiting

  • CTI Research Center

    Cincinnati 4508722, Ohio 5165418 45212
    United States

    Site Not Available

  • Intrepid Research

    Cincinnati 4508722, Ohio 5165418 45227
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Ohio Sleep Medicine Institute

    Dublin 5152333, Ohio 5165418 43017
    United States

    Site Not Available

  • Medical University of South Carolina - PPDS

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Medical University of South Carolina - PPDS

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Bogan Sleep Consultants, LLC

    Columbia 4575352, South Carolina 4597040 29201
    United States

    Site Not Available

  • Comprehensive Sleep Medicine Associates - Sugar Land

    Houston, Texas 77030
    United States

    Site Not Available

  • Sleep Therapy and Research Center

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Sleep Therapy and Research Center

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Children's Specialty Group

    Norfolk, Virginia 23510
    United States

    Active - Recruiting

  • Children's Specialty Group

    Norfolk 4776222, Virginia 6254928 23510
    United States

    Site Not Available

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