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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06505031
Registration number
NCT06505031
Ethics application status
Date submitted
11/07/2024
Date registered
17/07/2024
Date last updated
2/07/2025
Titles & IDs
Public title
A Study of TAK-861 in People With Narcolepsy Type 1
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
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Secondary ID [1]
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2024-511998-30-00
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Secondary ID [2]
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TAK-861-3002
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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 - Participants will receive TAK-861 tablets, orally, for 12 weeks.
Placebo comparator: Placebo - Participants will receive TAK-861-matching placebo tablets, orally, for 12 weeks.
Treatment: Drugs: TAK-861
Oral tablet.
Treatment: Drugs: Placebo
TAK-861-matching placebo tablet.
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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 12 in Mean Sleep Latency From the 4 Maintenance of Wakefulness Test (MWT) Wake Trials
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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 (trials) 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 12
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Secondary outcome [1]
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Change From Baseline to Week 12 in 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 12
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Secondary outcome [2]
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Weekly Cataplexy Rate (WCR) at Week 12
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Assessment method [2]
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change From Baseline to Week 12 in Mean Number of Lapses on the 3 Psychomotor Vigilance Test (PVT)
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Assessment method [3]
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The PVT is a simple reaction performance task that aims to measure sustained attention. The change from baseline in the mean number of lapses (delayed responses to a visual cue from intraday sessions) during the 10 minute test will be used as a measure of objective sustained attention.
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Timepoint [3]
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Baseline, Week 12
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Secondary outcome [4]
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Patient Global Impression of Change (PGI-C) Score at Week 12
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Assessment method [4]
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The PGI-C is a patient self-rated scale to assess improvement in daytime sleepiness and overall narcolepsy symptoms. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score
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Assessment method [5]
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The NSS-CT is a 15-item self-administered questionnaire that assesses the severity and consequences of the 5 major narcolepsy symptoms such as daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disturbed nighttime sleep (DNS) with a total score range of 0 to 57 (sum of 6 items that assess symptoms severity are rated using a six-point Likert scale \[0-5\] and 9 items that describe the symptom effect on daily life are rated using a four-point Likert scale \[0-3\]). Higher total scores mean a worse outcome.
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Timepoint [5]
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Baseline, Week 12
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Secondary outcome [6]
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Change From Baseline to Week 12 in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores
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Assessment method [6]
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The FINI measures the functional impacts of narcolepsy across 6 domains. Each domain is scored from 0 to 4, where 0 indicates the best health and 4 the worst.
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Timepoint [6]
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Baseline, Week 12
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Secondary outcome [7]
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Change From Baseline to Week 12 in Short Form-36 Survey (SF-36) Mental and Physical Component Scores
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Assessment method [7]
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The SF-36 is participant-reported survey of participant health that assesses the quality of life and includes both physical and mental components. The scores for each component range from 0 to 100. Higher scores represent better health-related quality of life.
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Timepoint [7]
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Baseline, Week 12
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Secondary outcome [8]
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Number of Participants with At Least one Treatment-Emergent Adverse Event (TEAE)
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Assessment method [8]
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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 [8]
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Up to 16 weeks
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Eligibility
Key inclusion criteria
1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m^2).
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].
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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: (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 any current unstable psychiatric disorder or current active major depressive episode (MDE) or an active MDE in the past 6 months.
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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 analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
7/11/2024
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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
4/06/2025
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Sample size
Target
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Accrual to date
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Final
105
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Takeda Site 1 - Glebe
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Recruitment postcode(s) [1]
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- Glebe
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Linz
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Belgium
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State/province [2]
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Alken
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Belgium
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Erpent
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Belgium
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State/province [4]
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Ghent
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Country [5]
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Belgium
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State/province [5]
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Leuven
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Country [6]
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Belgium
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State/province [6]
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Liege
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Country [7]
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China
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State/province [7]
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Beijing
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Country [8]
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China
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State/province [8]
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Henan
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Country [9]
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China
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State/province [9]
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Shanghai
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Country [10]
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China
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State/province [10]
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Guangdong
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Country [11]
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Finland
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State/province [11]
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Helsinki
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Finland
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State/province [12]
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Tampere
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France
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State/province [13]
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Bordeaux
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France
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State/province [14]
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Bron
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France
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State/province [15]
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Marseille
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France
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State/province [16]
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Montpellier
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France
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State/province [17]
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Nantes
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Italy
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State/province [18]
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Bologna
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Italy
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State/province [19]
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Pozzilli
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Italy
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State/province [20]
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Roma
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Korea, Republic of
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Daegu
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Korea, Republic of
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State/province [22]
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Gyeonggi-do
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Country [23]
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Korea, Republic of
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Seoul
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Country [24]
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Poland
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State/province [24]
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Krakow
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Country [25]
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Spain
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State/province [25]
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Barcelona
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Country [26]
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Spain
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State/province [26]
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Madrid
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Country [27]
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Sweden
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State/province [27]
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Uppsala
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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 learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.
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Trial website
https://clinicaltrials.gov/study/NCT06505031
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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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Country
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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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Takeda Contact
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Address
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Country
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Phone
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+1-877-825-3327
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06505031
Download to PDF