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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05687903
Registration number
NCT05687903
Ethics application status
Date submitted
9/01/2023
Date registered
18/01/2023
Date last updated
26/01/2024
Titles & IDs
Public title
A Study of TAK-861 in Participants With Narcolepsy Type 1
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Scientific title
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
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Secondary ID [1]
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2022-001654-38
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Secondary ID [2]
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TAK-861-2001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 1
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAK-861
Treatment: Drugs - Placebo
Experimental: TAK-861 Dose 1 - Participants will receive TAK-861 dose 1, orally, from Day 1 up to Weeks 8 or 12.
Experimental: TAK-861 Dose 2 - Participants will receive TAK-861 dose 2, orally, from Day 1 up to Weeks 8 or 12.
Experimental: TAK-861 Dose 3 - Participants will receive TAK-861 dose 3, orally, from Day 1 up to Weeks 8 or 12.
Experimental: TAK-861 Dose 4 - Participants will receive TAK-861 dose 4, orally, from Day 1 up to Weeks 8 or 12.
Placebo Comparator: Placebo - Participants will receive TAK-861 matching placebo tablets, orally, from Day 1 up to Weeks 8 or 12.
Treatment: Drugs: TAK-861
TAK-861 tablets
Treatment: Drugs: Placebo
TAK-861 placebo matching tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Baseline to Week 8 in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
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Assessment method [1]
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The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
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Timepoint [1]
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Baseline, Week 8
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Secondary outcome [1]
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Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
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Assessment method [1]
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The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
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Timepoint [1]
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Baseline, Week 8
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Secondary outcome [2]
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Weekly Cataplexy Rate at Week 8
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Assessment method [2]
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Timepoint [2]
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Week 8
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Secondary outcome [3]
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Occurrence of at Least One Related Treatment-emergent Adverse Event (TEAE)
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Assessment method [3]
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An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
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Timepoint [3]
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Baseline up to approximately 16 weeks
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Eligibility
Key inclusion criteria
1. The participant is aged 18 to 70 years, inclusive, at the time of signing the informed
consent form (ICF).
Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
2. The participant has body mass index (BMI) within the range 18 to 40 kilogram per
square meter [kg/m^2] (inclusive).
3. The participant has an International Classification of Sleep Disorders, 3rd Edition
(ICSD-3) diagnosis of narcolepsy type 1 (NT1) by polysomnography (PSG)/Multiple Sleep
Latency Test (MSLT), performed within the past 10 years.
4. The participant is positive for the human leukocyte antigen (HLA) genotype
HLA-DQB1*06:02 or results from cerebrospinal fluid (CSF) testing indicate the
participant's CSF orexin (OX)/hypocretin-1 concentration is <110 picograms per
milliliter ([pg/mL] (or less than one-third of the mean values obtained in normal
participants within the same standardized assay).
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Minimum age
16
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. The participant has a current medical disorder, other than narcolepsy with cataplexy,
associated with EDS.
2. The participant has medically significant hepatic or thyroid disease.
3. The participant has a history of cancer in the past 5 years (does not apply to
participants with carcinoma in situ that has been resolved without further treatment
or basal cell cancer).
4. The participant has clinically significant coronary artery disease, a history of
myocardial infarction, clinically significant angina, clinically significant cardiac
rhythm abnormality, or heart failure.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion, or has a family
history of inherited disorders associated with seizure (except for a single febrile
seizure in childhood).
7. The participant has one or more of the following psychiatric disorders:
1. Any current unstable psychiatric disorder.
2. Current or history of manic or hypomanic episode, schizophrenia or any other
psychotic disorder, including schizoaffective disorder, major depression with
psychotic features, bipolar depression with psychotic features, obsessive
compulsive disorder, intellectual disability, organic mental disorders, or mental
disorders due to a general medical condition as defined in the Diagnostic and
Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
3. Current diagnosis or history of substance use disorder as defined in the DSM-5.
4. Current active major depressive episode (MDE) or who have had an active MDE in
the past 6 months.
8. The participant has a history of cerebral ischemia, transient ischemic attack (<5
years ago), intracranial aneurysm, or arteriovenous malformation.
9. The participant has a positive test result for hepatitis B surface antigen, hepatitis
C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen.
10. The participant's renal creatinine clearance (Cockcroft-Gault Equation) is =50
mL/minute.
11. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
values >1.5 times the upper limit of normal (ULN).
12. The participant is considered by the investigator to be at imminent risk of suicide or
injury to self, others, or property, or the participant has attempted suicide within
the past year.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/12/2023
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Sample size
Target
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Accrual to date
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Final
112
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research, Sleep and Circadian Research Group - Glebe
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Recruitment postcode(s) [1]
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2037 - Glebe
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Florida
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United States of America
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Georgia
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Kansas
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Massachusetts
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Michigan
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Missouri
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North Carolina
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Ohio
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Virginia
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Finland
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Uusimaa
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France
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Haute-Garonne
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France
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Herault
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France
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Isere
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France
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Paris
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Bayern
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Germany
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Bologna
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Italy
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Lazio
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Italy
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Molise
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Japan
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Akita
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Japan
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Hukuoka
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Japan
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Kumamoto
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Nagakute
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Japan
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Yokohama
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Netherlands
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Noord-Brabant
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Noord-Holland
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Norway
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Oslo
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Spain
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Alava
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Spain
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Castellon
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Spain
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Valencia
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Spain
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Barcelona
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Madrid
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Sweden
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Vastra Gotalands Lan
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Switzerland
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Aargau (de)
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Switzerland
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Ticino (it)
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Switzerland
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including
excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in
the study across North America, Europe and Asia Pacific.
The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this
treatment period the participant will have the option to participate in a separate, long-
term extension study during which all participants will be treated with TAK-861.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05687903
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Takeda
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05687903
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