UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053326 |
|---|---|
| Receipt number | R000060866 |
| Scientific Title | Treatment preferences of patients with Parkinson's disease: a cross-sectional observational study |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2025/08/04 09:48:32 |
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Basic information
Public title
The survey about preferences for treatment of patients with Parkinson's disease
Acronym
The survey about preferences for treatment of patients with Parkinson's disease
Scientific Title
Treatment preferences of patients with Parkinson's disease: a cross-sectional observational study
Scientific Title:Acronym
Treatment preferences of patients with Parkinson's disease: a cross-sectional observational study
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the preferences for treatment of patients with Parkinson's disease using the discrete choice experiment methodology
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relative importance of attribute and preference weights of levels for anti-Parkinson's drugs
Key secondary outcomes
The subgroup analysis of primary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with a diagnosis of Parkinson's disease
2. Patients received treatments with anti-Parkinson's drugs when participating in the study
3. Patients being able to answer the online survey
4. Patients who consent to the study spring from their own free will
Key exclusion criteria
1. Patients being unable to answer the survey themselves or without someone who manipulates instead of patients
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ishida |
Organization
Eisai Co., Ltd.
Division name
Medical Headquarters
Zip code
112-8088
Address
Koishikawa 4-6-10, Bunkyo-ku, Tokyo
TEL
070-3762-8613
t8-ishida@hhc.eisai.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kogo |
Organization
Eisai Co., Ltd.
Division name
Medical Headquarters
Zip code
112-8088
Address
Koishikawa 4-6-10, Bunkyo-ku, Tokyo
TEL
070-7536-2322
Homepage URL
y2-kogo@hhc.eisai.co.jp
Sponsor or person
Institute
Eisai Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO MINS
Address
Dogenzaka 1-15-14, Shibuya-ku, Tokyo
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
| 2024 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1155/padi/9526138
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1155/padi/9526138
Number of participants that the trial has enrolled
207
Results
The three most important characteristics identified were the risk of dyskinesia, improvement of bothersome symptoms, and the risk of side effects other than dyskinesia. Latent class analysis identified three groups with different preferences for pharmacological treatments, suggesting that they had different backgrounds, such as disease severity.
Results date posted
| 2025 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the subjects was 65.2 years. Females accounted for 53.1% of the participants, and 62.8% of the patients experienced wearing-off.
Participant flow
Members of the Japan Parkinson's Disease Association participated in the study via online after consent from January 18 to February 13, 2024.A total of 208 responses were collected; after excluding one duplicate response, 207 patients comprised the full analysis set.
Adverse events
Adverse events were not evaluated.
Outcome measures
The relative importance of attribute and preference weights of levels for anti-Parkinson's drugs
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 02 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Observational study to reveal treatment preferences of patients with Parkinson's disease
Management information
Registered date
| 2024 | Year | 01 | Month | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060866
