UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062637 |
|---|---|
| Receipt number | R000071696 |
| Scientific Title | Questionnaire study on wearing-off in patients with Parkinson's disease |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/20 17:04:35 |
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Basic information
Public title
Questionnaire study on wearing-off in patients with Parkinson's disease
Acronym
Questionnaire study on wearing-off in patients with Parkinson's disease
Scientific Title
Questionnaire study on wearing-off in patients with Parkinson's disease
Scientific Title:Acronym
Questionnaire study on wearing-off in patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a questionnaire survey among patients with Parkinson's disease and to clarify the actual timing of symptom occurrence associated with wearing-off in Parkinson's disease.
Basic objectives2
Others
Basic objectives -Others
Types and frequency of symptoms showing day to day variability in wearingoff onset or occurrence during specific time periods and the impact on daily living treatment preferences and coping strategies according to the stage of wearingoff treatment.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Types of symptoms for which the duration from levodopa administration to wearingoff onset exhibits daytoday variability and the proportion of patients experiencing such variability.
Types of symptoms for which the presence or absence of wearingoff during specific time periods varies from day to day and the proportion of patients experiencing such variability.
The degree of impairment in daily living and intentions regarding treatment or coping strategies associated with daytoday variability in the duration to wearingoff onset and in the presence or absence of wearingoff during specific time periods.
Trends according to the stage of wearingoff treatment in the proportion of patients experiencing daytoday variability in the duration to wearingoff onset the proportion of patients experiencing daytoday variability in the presence or absence of wearingoff during specific time periods the degree of impairment in daily living and intentions regarding treatment or coping strategies.
Key secondary 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have provided informed consent to participate in this study.
2. Patients aged >=18 years at the time of consent.
3. Patients who self-report a confirmed diagnosis of Parkinson's disease.
4. Patients who take oral levodopa formulations at least three times per day.
Key exclusion criteria
1.Patients who self-report a physician diagnosis of dementia.
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kawashima |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Primary Medical , Medical Affairs
Zip code
541-8564
Address
8-2,Kyutaromachi 1-chome, Chuo-ku osaka-shi, Osaka
TEL
06-6263-5670
m.kawashima@ono-pharma.com
Public contact
Name of contact person
| 1st name | Yaoki |
| Middle name | |
| Last name | Sonohara |
Organization
Intage Healthcare Inc.
Division name
Marketing & Value Insight Division Value & Access Department HEOR Group
Zip code
101-0062
Address
13F Ochanomizu Sola City, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5294-8393
Homepage URL
sonohara.44124@intage.com
Sponsor or person
Institute
ONO PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
| 2026 | Year | 08 | Month | 24 | 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
| 2026 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective cross-sectional web-based questionnaire study in patients with Parkinson's disease. Patient-reported day-to-day variability in the duration from levodopa administration to wearing-off onset and in the occurrence of wearing-off during specific time periods will be assessed. Associations of such variability with impairment in daily living, intentions regarding treatment or coping strategies, and the stage of wearing-off treatment will also be examined. Participants will be recruited according to the predefined inclusion and exclusion criteria.
Management information
Registered date
| 2026 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071696
