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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
3/12/2024

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
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.
Trial website
https://clinicaltrials.gov/study/NCT06505031
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06505031