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

Last updated: September 24, 2024
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
2022-002965-13
jRCT2031230135
  • Ages 16-70
  • All Genders

Study Summary

The main aim is to evaluate the safety and tolerability of TAK-861 on 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 study withTAK-861, and for whom the investigator has no clinical objection to theirenrollment.

Exclusion

Exclusion criteria:

  1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at thetime of rollover related to the study drug from the parent study or discontinuedbecause of TEAEs in the parent study.

  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) or aspartate aminotransferase (AST) values >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 (<5 yearsago), 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 study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This study 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 study was initiated in parallel with the parent phase 2 studies, 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) study enrolled participants with both diagnoses from the two phase 2 studies. As the TAK-861-2002 study did not meet prespecified criteria, all participants with NT2 have been discontinued, and this extension study will only include participants with NT1 who previously completed a parent study. Additional parent studies include all TAK-861 phase 3 studies.

The study will enroll up to 500 patients. Participants will be assigned to one of the treatment groups according to the dose assigned to them in their parent study. Similarly, participants who were previously on a placebo dose will also be assigned to one of the treatment groups randomly. All participants in the study will receive TAK-861.

Participants with NT1 will receive the following dose from the parent study:

  • TAK-861 Dose 1

  • TAK-861 Dose 2

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to approximately 5 years. 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 study drug.

Connect with a study center

  • Woolcock Institute of Medical Research

    Glebe, New South Wales 2037
    Australia

    Active - Recruiting

  • Terveystalo Helsinki Sleep Clinic

    Helsinki, Uusimaa 00380
    Finland

    Active - Recruiting

  • CHRU Dijon Hopital General

    Dijon, Cote-d'Or 21079
    France

    Site Not Available

  • Hopital Pierre-Paul Riquet

    Toulouse, Haute-Garonne 31000
    France

    Active - Recruiting

  • CHU Gui De Chauliac

    Montpellier, Herault 34090
    France

    Active - Recruiting

  • CHU de Grenoble

    La Tronche, Isere 38700
    France

    Active - Recruiting

  • 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

  • Universitaet Regensburg am Bezirksklinikum

    Regensburg, Bayern 93053
    Germany

    Active - Recruiting

  • Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin, Mecklenburg-Vorpommern 19053
    Germany

    Active - Recruiting

  • 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

  • Klinische Forschung Hamburg

    Hamburg, 20253
    Germany

    Active - Recruiting

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Lazio 00133
    Italy

    Active - Recruiting

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

    Milano, Lombardia 20127
    Italy

    Site Not Available

  • Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Molise 86077
    Italy

    Active - Recruiting

  • Ospedale Bellaria

    Bellaria, 40139
    Italy

    Active - Recruiting

  • 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-Shi, Kumamoto 862-0954
    Japan

    Active - Recruiting

  • YOU ARIYOSHI Sleep Clinic

    Nagasaki-Shi, Nagasaki 850-0045
    Japan

    Active - Recruiting

  • Gokeikai Osaka Kaisei Hospital

    Osaka-Shi, Osaka 532-0003
    Japan

    Active - Recruiting

  • 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

  • RESM respiratory and sleep medical-care clinic

    Yokohama, 222-0033
    Japan

    Site Not Available

  • Kempenhaeghe - PPDS

    Heeze, Noord-Brabant 5591 VE
    Netherlands

    Active - Recruiting

  • Slaap-Waakcentrum SEIN Heemstede

    Heemstede, Noord-Holland 2103 SW
    Netherlands

    Active - Recruiting

  • University of Oslo

    Oslo, 0450
    Norway

    Active - Recruiting

  • Hospital Universitario Araba Santiago

    Vitoria, Alava 01009
    Spain

    Active - Recruiting

  • Hospital General de Castello

    Castellón De La Plana, Castellon 12004
    Spain

    Active - Recruiting

  • Hospital de La Ribera

    Alzira, Valencia 46600
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 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

  • Sahlgrenska University Hospital

    Goteborg, Vastra Gotalands Lan 413 46
    Sweden

    Active - Recruiting

  • Klinik Barmelweid AG

    Barmelweid, Aargau (de) 5017
    Switzerland

    Active - Recruiting

  • Neurocenter of Southern Switzerland

    Lugano, Ticino (it) 6900
    Switzerland

    Active - Recruiting

  • Universitaetsspital Bern - Inselspital

    Bern, 43017-3521
    Switzerland

    Active - Recruiting

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama 35213
    United States

    Active - Recruiting

  • 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

  • Delta Waves LLC - Hunt - PPDS

    Colorado Springs, Colorado 80918
    United States

    Active - Recruiting

  • Florida Pediatric Research Institute

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Neurotrials Research

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Georgia Neuro Center

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • 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

  • Henry Ford Medical Center - Columbus

    Novi, Michigan 48377
    United States

    Active - Recruiting

  • 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

  • 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

  • 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

  • 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

  • Children's Specialty Group

    Norfolk, Virginia 23510
    United States

    Active - Recruiting

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