UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030394 |
|---|---|
| Receipt number | R000034707 |
| Scientific Title | Exploratory investigation of pathomechanisms,prognosis and quality of life in Parkinson's disease and parkinsonian syndrome |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2023/06/19 16:49:30 |
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Basic information
Public title
Exploratory investigation of pathomechanisms,prognosis and quality of life in Parkinson's disease and parkinsonian syndrome
Acronym
Exploratory investigation of pathomechanisms in Parkinson's disease and parkinsonian syndrome
Scientific Title
Exploratory investigation of pathomechanisms,prognosis and quality of life in Parkinson's disease and parkinsonian syndrome
Scientific Title:Acronym
Exploratory investigation of pathomechanisms in Parkinson's disease and parkinsonian syndrome
Region
| Japan |
Condition
Condition
Parkinson's disease and parkinsonian syndrome
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the pathomechanisms, prognosis and quality of life in Parkinson's disease and parkinsonian syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor functions (Unified Parkinson's disease rating scale:UPDRS)
Key secondary outcomes
QOL (Parkinson's disease questionnaire-39)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease or parkinsonian syndrome
Key exclusion criteria
Patients disqualified by doctor in attendance with any reason
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamamoto |
Organization
Chiba University Graduate School Of Medicine
Division name
Neurology
Zip code
260-867
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
043-222-7171
tatsuya-yamamoto@mbc.nifty.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamamoto |
Organization
Chiba University Graduate School Of Medicine
Division name
Neurology
Zip code
260-8670
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
tatsuya-yamamoto@mbc.nifty.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University Graduate School of Medicine Review Board
Address
1-8-1 Inohana Chuo-ku Chiba, Japan
Tel
043-222-7171
tatsuya-yamamoto@mbc.nifty.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
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
80
Results
We are continuing to evaluate changes over time in motor function, cognitive function, and QOL in Parkinson's disease.
Results date posted
| 2023 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient with advanced-stage of Parkinson's disease
Participant flow
Enrollment of eligible patients after an outpatient visit
Adverse events
No adverse events
Outcome measures
Evaluation of motor symptoms and ADL by UPDRS
Evaluation of cognitive function by MMSE and FAB
QOL assessment by PDQ-39
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examination of questionnaire, neurological findings and laboratory findings.
Management information
Registered date
| 2017 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034707
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
