Phase
Condition
Narcolepsy
Treatment
TAK-861
Placebo
Clinical Study ID
Ages 16-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant has a body mass index (BMI) within the range 18 to 40 kilograms permeter square (kg/m^2).
The participant has an International Classification of Sleep Disorders, ThirdEdition (ICSD-3) or International Classification of Sleep Disorders, Third Edition,Text Revision (ICSD-3-TR) diagnosis of NT1.
The participant has greater than or equal to (≥)4 partial or complete episodes ofcataplexy/week (WCR).
The participant is positive for the human leukocyte antigen (HLA) genotypeHLA-DQB1*06:02 or results from radioimmunoassay indicate the participant'scerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than orequal to (≤)110 picograms per milliliter (pg/mL) [or less than one-third of the meanvalues obtained in normal participants within the same standardized assay].
Exclusion
Exclusion Criteria:
The participant has a current medical disorder, other than narcolepsy withcataplexy, associated with EDS.
The participant: (a) has a history of myocardial infarction; (b) has a history ofclinically significant hepatic disease, thyroid disease, coronary artery disease,cardiac rhythm abnormality or heart failure; or (c) has any medical condition (suchas unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
The participant has current or recent (within 6 months) gastrointestinal diseasethat is expected to influence the absorption of drugs.
The participant has a history of cancer in the past 5 years.
The participant has a clinically significant history of head injury or head trauma.
The participant has a history of epilepsy, seizure, or convulsion.
The participant has a history of cerebral ischemia, transient ischemic attack (<5years from screening), intracranial aneurysm, or arteriovenous malformation.
Study Design
Study Description
Connect with a study center
Takeda Site 21
Ottawa, Ontario K2A 3Z3
CanadaSite Not Available
Takeda Site 11
Toronto, Ontario M5S 3A3
CanadaSite Not Available
Takeda Site 50
Montreal, Quebec H4J 1C5
CanadaSite Not Available
Takeda Site 25
Montpellier, Herault 34090
FranceSite Not Available
Takeda Site 43
Toulouse, Midi-Pyrenees 31059
FranceSite Not Available
Takeda Site 40
Lyon, 69004
FranceSite Not Available
Takeda Site 29
Paris, 75013
FranceSite Not Available
Takeda Site 47
Regensberg, Bayern 93053
GermanySite Not Available
Takeda Site 34
Berlin, 10117
GermanySite Not Available
Takeda Site 26
Schwerin, 19053
GermanySite Not Available
Takeda Site 32
Roma, Lazio OO133
ItalySite Not Available
Takeda Site 30
Bologna, 40139
ItalySite Not Available
Takeda Site 16
Kurume-shi, Fukuka-Ken 830-0011
JapanSite Not Available
Takeda Site 13
Kitakyushu-shi, Fukuoka 802-0084
JapanSite Not Available
Takeda Site 14
Fukuoka, Fukuoka-Shi Hakata-Ku 812-0025
JapanSite Not Available
Takeda Site 9
Kohoku, Kanagawa 222-0033
JapanSite Not Available
Takeda Site 7
Kumamoto-shi, Kumamoto-Ken 861-0954
JapanSite Not Available
Takeda Site 17
Isahaya-shi, Nagasaki-Ken 854-0081
JapanSite Not Available
Takeda Site 15
Urasoe-Shi, Okinawa 901-2132
JapanSite Not Available
Takeda Site 12
Yodogawa, Osaka 532-0003
JapanSite Not Available
Takeda Site 8
Bunkyo-ku, Tokyo 112-0012
JapanSite Not Available
Takeda Site 19
Kodaira-shi, Tokyo 187-8551
JapanSite Not Available
Takeda Site 20
Shibuya-ku, Tokyo 151-0053
JapanSite Not Available
Takeda Site 28
Zwolle,
NetherlandsSite Not Available
Takeda Site 27
Bergen, Hordaland 5021
NorwaySite Not Available
Takeda Site 33
Oslo, 450
NorwaySite Not Available
Takeda Site 37
Vitoria, Alava 1004
SpainSite Not Available
Takeda Site 38
Castello de la Plana, Castellon 12004
SpainSite Not Available
Takeda Site 35
Barcelona, 8035
SpainSite Not Available
Takeda Site 36
Barcelona, O8036
SpainSite Not Available
Takeda Site 24
Madrid, 28046
SpainSite Not Available
Takeda Site 41
Valencia, 46600
SpainSite Not Available
Takeda Site 22
Barmelweid, Aargau 5017
SwitzerlandSite Not Available
Takeda Site 23
Bern, 3010
SwitzerlandSite Not Available
Takeda Site 51
Lugano, CH-6900
SwitzerlandSite Not Available
Takeda Site 46
Cambridge, CB2 OAY
United KingdomSite Not Available
Takeda Site 52
London, SE1 9RT
United KingdomSite Not Available
Takeda Site 53
London, W1G 9ST
United KingdomSite Not Available
Takeda Site 48
Phoenix, Arizona 85054
United StatesSite Not Available
Takeda Site 39
Redwood City, California 94063
United StatesSite Not Available
Takeda Site 31
Santa Ana, California 92705
United StatesSite Not Available
Takeda Site 18
Upland, California 91786
United StatesSite Not Available
Takeda Site 4
Orlando, Florida 32803
United StatesSite Not Available
Takeda Site 3
Atlanta, Georgia 30328
United StatesSite Not Available
Takeda Site 45
Boston, Massachusetts 02115
United StatesSite Not Available
Takeda Site 5
Saint Louis, Missouri 63123
United StatesSite Not Available
Takeda Site 2
Denver, North Carolina 28037
United StatesSite Not Available
Takeda Site 6
Cincinnati, Ohio 45227
United StatesSite Not Available
Takeda Site 42
Cleveland, Ohio 44195
United StatesSite Not Available
Takeda Site 49
Danville, Pennsylvania 17821
United StatesSite Not Available
Takeda Site 1
Columbia, South Carolina 29201
United StatesSite Not Available
Takeda Site 44
Dallas, Texas 75231
United StatesSite Not Available
Takeda Site 10
Norfolk, Virginia 23510
United StatesSite Not Available
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