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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/NCT05687916
Registration number
NCT05687916
Ethics application status
Date submitted
9/01/2023
Date registered
18/01/2023
Date last updated
17/05/2024
Titles & IDs
Public title
A Study of TAK-861 in Participants With Narcolepsy Type 2
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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 Without Cataplexy (Narcolepsy Type 2)
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Secondary ID [1]
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2022-002966-34
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Secondary ID [2]
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TAK-861-2002
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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 2
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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 - TAK-861 dose 1, orally for 8 weeks.
Experimental: TAK-861 Dose 2 - TAK-861 dose 2, orally for 8 weeks.
Placebo Comparator: Placebo - TAK-861 matching placebo tablets, orally for 8 weeks.
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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Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE)
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Assessment method [2]
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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 [2]
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From baseline up to approximately 12 weeks
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Eligibility
Key inclusion criteria
- 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.
- The participant has an International Classification of Sleep Disorders, 3rd edition
(ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test
(MSLT), performed within the past 5 years.
Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal
polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the
site may repeat the diagnostic PSG/MSLT.
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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
- The participant has a current medical disorder, other than narcolepsy without
cataplexy, associated with EDS.
- 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).
- 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, mental retardation, 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.
Note: If the history of substance use disorder is more than 12 months before
baseline, the participant may be allowed to enroll in the study after
consultation with the sponsor or designee. (Participant must also have negative
urine drug screen at the screening and Day -2 visit.)
4. Current active major depressive episode (MDE) or who have had an active MDE in
the past 6 months.
- The participant has a history of cerebral ischemia, transient ischemic attack (<5
years ago), intracranial aneurysm, or arteriovenous malformation.
- The participant had major surgery or donated or lost 1 unit of blood (approximately
500 mL) within 4 weeks before the screening visit.
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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 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
25/12/2023
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Sample size
Target
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Accrual to date
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Final
71
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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 - 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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Arizona
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California
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Colorado
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Georgia
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Massachusetts
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Michigan
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Missouri
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Ohio
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Texas
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Virginia
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Finland
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Uusimaa
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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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Germany
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Mecklenburg-Vorpommern
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Germany
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Berlin
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Italy
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Lazio
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Italy
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Molise
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Italy
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Bellaria
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Japan
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Akita
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Japan
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Ehime
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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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Spain
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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 is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including
excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of
Wakefulness Test (MWT).
The study will enroll approximately 60 participants and they will be randomly assigned to 3
groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the
participants will receive the treatment for 8 weeks. Participants will be asked to complete
some questionnaires during the study. This trial will be conducted in North America, Europe,
and Asia Pacific.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05687916
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05687916
Download to PDF