UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060284 |
|---|---|
| Receipt number | R000068963 |
| Scientific Title | Survey on the burden of sialorrhea symptoms in patients with parkinson's disease |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 15:56:40 |
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Basic information
Public title
Survey on the burden of sialorrhea symptoms in patients with parkinson's disease
Acronym
Survey on the burden of sialorrhea symptoms in patients with parkinson's disease
Scientific Title
Survey on the burden of sialorrhea symptoms in patients with parkinson's disease
Scientific Title:Acronym
Survey on the burden of sialorrhea symptoms 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
To clarify the comparative impact of sialorrhea against other motor symptoms (MS) and non-motor symptoms (NMS) on the daily functioning of patients with parkinson's disease (PD)
Basic objectives2
Others
Basic objectives -Others
To investigate the perceived burden of MS and NMS, and the impact of sialorrhea on QOL in patients with PD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total score and selection percentage for each symptom, based on a weighted ranking (1st rank = 5 points, 2nd = 4 points, 3rd = 3 points, 4th = 2 points, 5th = 1 point), derived from the top five most bothersome clinical symptoms (MS/NMS) experienced by Japanese PD patients in their daily life over the past month
Key secondary outcomes
-The total score and selection percentage for each symptom, based on a weighted ranking (1st rank = 5 points, 2nd = 4 points, 3rd = 3 points, 4th = 2 points, 5th = 1 point), derived from the top five most bothersome clinical symptoms (MS/NMS) experienced by Japanese PD patients in their daily life over the past month, within subgroups stratified by patient demographic and clinical characteristics
-Patient demographic and clinical characteristics stratified by the specific symptom chosen as most bothersome
-Results of supplementary questions regarding the impact of sialorrhea on QOL components (specific effects on constituents of QOL) targeting study participants who reported experiencing sialorrhea
-Results of the supplementary questions regarding the impact on QOL within subgroups of participants who reported experiencing sialorrhea, specifically cohorts stratified by patient demographic and clinical characteristics, and those comparing patients who ranked sialorrhea among their top five most bothersome clinical symptoms versus those who did not
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 affiliated with PD patient organizations (specifically, the Kibou-no-kai for Young-Onset Parkinson's Disease and the Japan Parkinson's Disease Association)
2) Patients diagnosed with PD at least one month prior to the survey
3) Individuals aged 18 years or older, regardless of gender
4) Patients capable of self-completing the survey (assistance from a caregiver for input is permissible)
5) Patients able to provide voluntary informed consent for participation in this study
Key exclusion criteria
Patients currently participating in any interventional clinical trial
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Nishikawa |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
n.nishikawa.ts@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Sakurako |
| Middle name | |
| Last name | Okayasu |
Organization
QLife Inc.
Division name
Strategic Solution Planning & Development Dept
Zip code
105-0001
Address
10F, Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
Homepage URL
pd_drool@qlife.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Japan Conference of Clinical Research
Address
1-13-23 Minami-Ikebukuro. Toshima-ku, Tokyo 171-0022
Tel
03-6868-7022
c-irb_ug@neues.co.jp
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 | 01 | Month | 07 | 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 | 11 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design and Methods
This study employed a cross-sectional, non-interventional, quantitative study design utilizing a questionnaire. A questionnaire was developed to assess the bothersomeness of MS and NMS experienced by Japanese PD patients in their daily life over the past month. The questionnaire forms will be distributed to patients through Parkinson's disease patient associations (specifically, the Kibou-no-kai for Young-Onset Parkinson's Disease and the Japan Parkinson's Disease Association). The returned, completed questionnaires will be then analyzed.
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068963
