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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05687916




Registration number
NCT05687916
Ethics application status
Date submitted
9/01/2023
Date registered
18/01/2023

Titles & IDs
Public title
A Study of TAK-861 in Participants With Narcolepsy Type 2
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)
Secondary ID [1] 0 0
2022-002966-34
Secondary ID [2] 0 0
TAK-861-2002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 2 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline to Week 8 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT)
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [1] 0 0
Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [2] 0 0
Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE)
Timepoint [2] 0 0
From baseline up to approximately 12 weeks

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.
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/12/2023
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
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United States of America
State/province [11] 0 0
Ohio
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United States of America
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South Carolina
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United States of America
State/province [13] 0 0
Texas
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United States of America
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Virginia
Country [15] 0 0
Finland
State/province [15] 0 0
Uusimaa
Country [16] 0 0
France
State/province [16] 0 0
Herault
Country [17] 0 0
France
State/province [17] 0 0
Isere
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
Germany
State/province [19] 0 0
Mecklenburg-Vorpommern
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Italy
State/province [21] 0 0
Lazio
Country [22] 0 0
Italy
State/province [22] 0 0
Molise
Country [23] 0 0
Italy
State/province [23] 0 0
Bellaria
Country [24] 0 0
Japan
State/province [24] 0 0
Akita
Country [25] 0 0
Japan
State/province [25] 0 0
Ehime
Country [26] 0 0
Japan
State/province [26] 0 0
Hukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Kumamoto
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Japan
State/province [30] 0 0
Nagakute
Country [31] 0 0
Japan
State/province [31] 0 0
Yokohama
Country [32] 0 0
Netherlands
State/province [32] 0 0
Noord-Brabant
Country [33] 0 0
Netherlands
State/province [33] 0 0
Noord-Holland
Country [34] 0 0
Norway
State/province [34] 0 0
Oslo
Country [35] 0 0
Spain
State/province [35] 0 0
Alava
Country [36] 0 0
Spain
State/province [36] 0 0
Castellon
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Sweden
State/province [40] 0 0
Vastra Gotalands Lan
Country [41] 0 0
Switzerland
State/province [41] 0 0
Aargau (de)
Country [42] 0 0
Switzerland
State/province [42] 0 0
Ticino (it)
Country [43] 0 0
Switzerland
State/province [43] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


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/NCT05687916