A Study of TAK-861 for the Treatment of Narcolepsy Type 1
NCT ID: NCT06470828
Last Updated: 2025-07-01
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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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2024-07-02
2025-06-03
Brief Summary
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Detailed Description
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The study will enroll approximately 152 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups:
1. TAK-861 Dose 1
2. TAK-861 Dose 2
3. Placebo
The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.
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 tablets at dose 1, orally, for 12 weeks.
TAK-861
Oral tablet.
TAK-861 Dose 2
Participants will receive TAK-861 tablets at dose 2, orally, for 12 weeks.
TAK-861
Oral tablet.
Placebo
Participants will receive TAK-861-matching placebo tablets, orally, for 12 weeks.
Placebo
TAK-861-matching placebo tablet.
Interventions
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TAK-861
Oral tablet.
Placebo
TAK-861-matching placebo tablet.
Eligibility Criteria
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Inclusion Criteria
2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
3. The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) \[or less than one-third of the mean values obtained in normal participants within the same standardized assay\].
Exclusion Criteria
2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
4. The participant has a history of cancer in the past 5 years.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has a history of epilepsy, seizure, or convulsion.
7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
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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Takeda Site 48
Phoenix, Arizona, United States
Takeda Site 39
Redwood City, California, United States
Takeda Site 31
Santa Ana, California, United States
Takeda Site 18
Upland, California, United States
Takeda Site 4
Orlando, Florida, United States
Takeda Site 3
Atlanta, Georgia, United States
Takeda Site 45
Boston, Massachusetts, United States
Takeda Site 5
St Louis, Missouri, United States
Takeda Site 2
Denver, North Carolina, United States
Takeda Site 6
Cincinnati, Ohio, United States
Takeda Site 42
Cleveland, Ohio, United States
Takeda Site 49
Danville, Pennsylvania, United States
Takeda Site 1
Columbia, South Carolina, United States
Takeda Site 44
Dallas, Texas, United States
Takeda Site 10
Norfolk, Virginia, United States
Takeda Site 21
Ottawa, Ontario, Canada
Takeda Site 11
Toronto, Ontario, Canada
Takeda Site 50
Montreal, Quebec, Canada
Takeda Site 25
Montpellier, Herault, France
Takeda Site 43
Toulouse, Midi-Pyrenees, France
Takeda Site 40
Lyon, , France
Takeda Site 29
Paris, , France
Takeda Site 47
Regensberg, Bavaria, Germany
Takeda Site 34
Berlin, , Germany
Takeda Site 26
Schwerin, , Germany
Takeda Site 32
Rome, Lazio, Italy
Takeda Site 30
Bologna, , Italy
Takeda Site 16
Kurume-shi, Fukuka-Ken, Japan
Takeda Site 13
Kitakyushu-shi, Fukuoka, Japan
Takeda Site 14
Fukuoka, Fukuoka-Shi Hakata-Ku, Japan
Takeda Site 9
Kohoku, Kanagawa, Japan
Takeda Site 7
Kumamoto, Kumamoto, Japan
Takeda Site 17
Isahaya-shi, Nagasaki, Japan
Takeda Site 15
Urasoe-Shi, Okinawa, Japan
Takeda Site 12
Yodogawa, Osaka, Japan
Takeda Site 8
Bunkyo-ku, Tokyo, Japan
Takeda Site 19
Kodaira-shi, Tokyo, Japan
Takeda Site 20
Shibuya-ku, Tokyo, Japan
Takeda Site 28
Zwolle, , Netherlands
Takeda Site 27
Bergen, Hordaland, Norway
Takeda Site 33
Oslo, , Norway
Takeda Site 37
Vitoria-Gasteiz, Alava, Spain
Takeda Site 38
Castellon, Castellon, Spain
Takeda Site 35
Barcelona, , Spain
Takeda Site 36
Barcelona, , Spain
Takeda Site 24
Madrid, , Spain
Takeda Site 41
Valencia, , Spain
Takeda Site 22
Barmelweid, Canton of Aargau, Switzerland
Takeda Site 23
Bern, , Switzerland
Takeda Site 51
Lugano, , Switzerland
Takeda Site 46
Cambridge, , United Kingdom
Takeda Site 52
London, , United Kingdom
Takeda Site 53
London, , United Kingdom
Countries
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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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2023-508465-32-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2051240083
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-861-3001
Identifier Type: -
Identifier Source: org_study_id
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