UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048177 |
|---|---|
| Receipt number | R000054899 |
| Scientific Title | Questionnaire study on non-motor symptoms in patients with Parkinson's disease |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2024/06/11 08:51:32 |
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Basic information
Public title
Questionnaire study on non-motor symptoms in patients with Parkinson's disease
Acronym
Questionnaire study on non-motor symptoms in patients with Parkinson's disease
Scientific Title
Questionnaire study on non-motor symptoms in patients with Parkinson's disease
Scientific Title:Acronym
Questionnaire study on non-motor 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
We will conduct a questionnaire survey on the occurrence and timing of non-motor symptoms, their impact on quality of life, and other symptoms in patients with Parkinson's disease, with the aim of understanding the unmet medical needs of patients in terms of treatment and medical coordination that they desire.
Basic objectives2
Others
Basic objectives -Others
Percentage of non-motor symptoms with Wearing off
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of non-motor symptoms with Wearing off
Key secondary outcomes
Department of initial medical examination and its percentage
Types of initial symptoms and their rates
Time from initial visit to PD diagnosis by department
Non-motor symptoms at the time of WO diagnosis
Percentage of drug (levodopa) responsiveness of non-motor symptoms at diagnosis of WO, by duration of illness, and impact on quality of life
Percentage of motor and non-motor symptoms by patient background
Description of each symptom by the patient to the physician
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
Parkinson's disease patients 18 years of age and older who belong to Japan Parkinson's Disease Association and their family members/caregivers
Key exclusion criteria
None
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Kinoshita |
Organization
Ono Pharmaceutical CO, LTD
Division name
Primary Medical , Medical Affairs
Zip code
541-8564
Address
8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka
TEL
06-6263-2992
f.kinoshita@ono.co.jp
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | Seki |
Organization
Intage Healthcare Inc.
Division name
Marketing Insight Division Medical Solution Department Consulting Group
Zip code
101-0062
Address
13F Ochanomizu Sola City, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5294-8393
Homepage URL
haruhiko.seki@intage.com
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
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
| 2022 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jsnt/41/1/41_49/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jsnt/41/1/41_49/_article/-char/ja/
Number of participants that the trial has enrolled
1301
Results
In patients taking levodopa preparations,the most common non-motor symptoms associated with wearing-off were "pain" and "feeling tired" in 13.5%, followed by "sometimes difficulty breathing" in 12.0%, "lack of energy" in 9.8%,"restless legs" in 9.0%, and "frequent mood changes, depression, or anxiety/panic" in 8.9%.
The proportion of patients who reported any non-motor symptoms was 47.9%.
Results date posted
| 2024 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who meet all the following criteria
1.Be a member of the Japan Parkinson's Disease Association
2.Have given written informed consent to participate in the research
3.Have Parkinson's disease and be aged 18 years at the time ofinformed consent
Participant flow
A survey request sent by mail to patients affiliated with the "National Parkinson's Disease Association
Adverse events
Not exit
Outcome measures
Primary Endpoint
Incidence of Non-motor Symptoms Associated with Wearing-off
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054899
