A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
NCT ID: NCT05816382
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
500 participants
INTERVENTIONAL
2023-04-05
2028-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAK-861 Dose 1
Participants will receive TAK-861 dose 1 for up to approximately 5 years.
TAK-861
TAK-861 tablets
TAK-861 Dose 2
Participants will receive TAK-861 dose 2 for up to approximately 5 years.
TAK-861
TAK-861 tablets
Interventions
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TAK-861
TAK-861 tablets
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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) 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 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 (\<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.
16 Years
70 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado, United States
Florida Pediatric Research Institute
Orlando, Florida, United States
Neurotrials Research
Atlanta, Georgia, United States
Georgia Neuro Center
Gainesville, Georgia, United States
Neurocare Inc
Newton, Massachusetts, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, United States
Research Carolina Elite
Denver, North Carolina, United States
ARSM Research, LLC
Huntersville, North Carolina, United States
CTI Research Center
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Medical University of South Carolina - PPDS
Charleston, South Carolina, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Sleep Therapy and Research Center
San Antonio, Texas, United States
Children's Specialty Group
Norfolk, Virginia, United States
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
Terveystalo Helsinki Sleep Clinic
Helsinki, Uusimaa, Finland
Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne, France
CHU Gui De Chauliac
Montpellier, Herault, France
CHU de Grenoble
La Tronche, Isere, France
Hopital de la Pitie Salpetriere
Paris, , France
Universitaet Regensburg am Bezirksklinikum
Regensburg, Bavaria, Germany
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany
Charite - Universitatsmedizin Berlin
Berlin, , Germany
Klinische Forschung Hamburg
Hamburg, , Germany
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, Italy
Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, Italy
Ospedale Bellaria
Bellaria, , Italy
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Howakai Kuwamizu Hospital
Kumamoto, Kumamoto, Japan
YOU ARIYOSHI Sleep Clinic
Nagasaki, Nagasaki, Japan
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, Japan
Koishikawa Tokyo Hospital
Bunkyo-Ku, Tokyo, Japan
Aichi Medical University Hospital
Nagakute, , Japan
Kempenhaeghe - PPDS
Heeze, North Brabant, Netherlands
Slaap-Waakcentrum SEIN Heemstede
Heemstede, North Holland, Netherlands
University of Oslo
Oslo, , Norway
Hospital Universitario Araba Santiago
Vitoria-Gasteiz, Alava, Spain
Hospital General de Castello
Castellon, Castellon, Spain
Hospital de La Ribera
Alzira, Valencia, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Instituto de Investigaciones del Sueno
Madrid, , Spain
Hospital Vithas Madrid Arturo Soria
Madrid, , Spain
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Klinik Barmelweid AG
Barmelweid, Aargau (de), Switzerland
Neurocenter of Southern Switzerland
Lugano, Ticino (it), Switzerland
Universitaetsspital Bern - Inselspital
Bern, , Switzerland
Countries
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Central Contacts
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Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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U1111-1283-1888
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230135
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-508462-15
Identifier Type: OTHER
Identifier Source: secondary_id
TAK-861-2003
Identifier Type: -
Identifier Source: org_study_id
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