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 any current unstable psychiatric disorder or current activemajor depressive episode (MDE) or an active MDE in the past 6 months.
Study Design
Study Description
Connect with a study center
Takeda Site 1
Glebe, New South Wales
AustraliaSite Not Available
Takeda Site 22
Linz, 4020
AustriaSite Not Available
Takeda Site 2
Alken,
BelgiumSite Not Available
Takeda Site 3
Erpent, 5101
BelgiumSite Not Available
Takeda Site 25
Ghent, 9000
BelgiumSite Not Available
Takeda Site 24
Leuven, 3000
BelgiumSite Not Available
Takeda Site 23
Liege, 4000
BelgiumSite Not Available
Takeda Site 4
Beijing, Beijing
ChinaSite Not Available
Takeda Site 27
Zhengzhou, Henan
ChinaSite Not Available
Takeda Site 28
Shanghai, Shanghai
ChinaSite Not Available
Takeda Site 26
Guangdong,
ChinaSite Not Available
Takeda Site 20
Helsinki, 380
FinlandSite Not Available
Takeda Site 21
Tampere, 33520
FinlandSite Not Available
Takeda Site 16
Leon, Bordeaux 33076
FranceSite Not Available
Takeda Site 6
Bron,
FranceSite Not Available
Takeda Site 14
Marseille, 13385
FranceSite Not Available
Takeda Site 5
Montpellier,
FranceSite Not Available
Takeda Site 15
Nantes, 44093
FranceSite Not Available
Takeda Site 6
Paris, 75013
FranceSite Not Available
Takeda Site 7
Bologna, 40139
ItalySite Not Available
Takeda Site 17
Pozzilli, 86077
ItalySite Not Available
Takeda Site 8
Roma,
ItalySite Not Available
Takeda Site 11
Seoul, Daegu 41931
Korea, Republic ofSite Not Available
Takeda Site 10
Suwon, Gyeonggi-do 16247
Korea, Republic ofSite Not Available
Takeda Site 12
Seoul, 3080
Korea, Republic ofSite Not Available
Takeda Site 9
Krakow,
PolandSite Not Available
28003
Barcelona, 08035
SpainSite Not Available
Takeda Site 13
Madrid,
SpainSite Not Available
Takeda Site 19
Uppsala,
SwedenSite Not Available
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