UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059563 |
|---|---|
| Receipt number | R000068123 |
| Scientific Title | Burden of Illness Study among Patients with Narcolepsy or Idiopathic Hypersomnia in Japan |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/28 09:36:42 |
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Basic information
Public title
Burden of Illness Study among Patients with Narcolepsy or Idiopathic Hypersomnia in Japan
Acronym
Burden of Illness Study among Patients with Narcolepsy or Idiopathic Hypersomnia
Scientific Title
Burden of Illness Study among Patients with Narcolepsy or Idiopathic Hypersomnia in Japan
Scientific Title:Acronym
Burden of Illness Study among Patients with Narcolepsy or Idiopathic Hypersomnia
Region
| Japan |
Condition
Condition
Narcolepsy, Idiopathic hypersomnia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimate total costs and EuroQol-5 Dimension (EQ-5D)-derived health utilities among patients with Narcolepsy type 1, Narcolepsy type 2, and Idiopathic hypersomnia summarized by disease severity levels measured by the Japanese version of the Epworth Sleepiness Scale.
Basic objectives2
Others
Basic objectives -Others
- Estimate the association between symptoms and costs and health utilities, among patients with NT1, NT2, and IH.
- Describe HCRU in relation to disease type and severity measured by JESS, among patients with NT1, NT2, and IH.
- Investigate the association of disease severity measured by JESS with education, work status, and work performance, among patients with NT1, NT2, and IH.
- Describe the impact of disease severity measured by JESS on ability to operate motor vehicles, among patients with NT1, NT2, and IH.
- Conduct the analyses of the primary objective and secondary objectives 1-4 using disease severity measured by ESS instead of JESS.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Total Cost and Health utilities
Key secondary outcomes
- Estimate the association between symptoms and costs and health utilities, among patients with NT1, NT2, and IH.
- Describe HCRU in relation to disease type and severity measured by JESS, among patients with NT1, NT2, and IH.
- Investigate the association of disease severity measured by JESS with education, work status, and work performance, among patients with NT1, NT2, and IH.
- Describe the impact of disease severity measured by JESS on ability to operate motor vehicles, among patients with NT1, NT2, and IH.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Having a self-reported diagnosis of narcolepsy or IH
2. Aged 18 years or older at the time of enrolment into study
3. Can read and understand Japanese
4. Willing to participate in the study and complete the questionnaire, and have accepted the informed consent form
Key exclusion criteria
Currently enrolled in any clinical trial
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takeumi |
| Middle name | |
| Last name | Kaneko |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3278-2111
takeumi.kaneko@takeda.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Osada |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, Japan
TEL
03-3278-2111
Homepage URL
yu.osada@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401, Mita, Minato-ku, Tokyo, 108-0073, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional observational survey of patients with narcolepsy and idiopathic hypersomnia in Japan. The purpose is to clarify the quality of life and costs of these patients through questionnaires conducted on paper or via the web.
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068123
