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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

Titles & IDs
Public title
A Study of TAK-861in People With Narcolepsy Type 1
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)
Secondary ID [1] 0 0
2024-511998-30-00
Secondary ID [2] 0 0
TAK-861-3002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 1 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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Epworth Sleepiness Scale (ESS) Total Score at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Weekly Cataplexy Rate (WCR) at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Number of Lapses on the 3 Post Meridiem (PM) Psychomotor Vigilance Test (PVT) Session at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Patient Global Impression of Change (PGI-C) Score at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Short Form-36 Survey (SF-36) Mental and Physical Component Scores at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Number of Participants with At Least one Treatment-Emergent Adverse Event (TEAE)
Timepoint [8] 0 0
Up to 16 weeks

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 =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 =110 picograms per milliliter (pg/mL) [or less than one-third of the mean values obtained in normal participants within the same standardized assay].
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/07/2026
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Takeda Site 1 - Glebe
Recruitment postcode(s) [1] 0 0
- Glebe
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Alken
Country [2] 0 0
Belgium
State/province [2] 0 0
Erpent
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
France
State/province [4] 0 0
Montpellier
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Italy
State/province [6] 0 0
Bologna
Country [7] 0 0
Italy
State/province [7] 0 0
Roma
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Daegu
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Poland
State/province [11] 0 0
Krakow
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid

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
Takeda Contact
Address 0 0
Country 0 0
Phone 0 0
+1-877-825-3327
Fax 0 0
Email 0 0
medinfoUS@takeda.com
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/NCT06505031