UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028752 |
|---|---|
| Receipt number | R000032409 |
| Scientific Title | prospective cohort for investigating progression marker of Parkinsonian syndromes |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2022/03/31 14:40:09 |
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Basic information
Public title
prospective cohort for investigating progression marker of Parkinsonian syndromes
Acronym
Cohort for investigating Progression marker Study in Parkinsonism (COPS-P)
Scientific Title
prospective cohort for investigating progression marker of Parkinsonian syndromes
Scientific Title:Acronym
Cohort for investigating Progression marker Study in Parkinsonism (COPS-P)
Region
| Japan |
Condition
Condition
Parkinsonism
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
investigating progression marker for Parkinsonism
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MDS-UPDRSscore
Key secondary outcomes
DaTSPECT
Non-motor symptom Scale
Barthal Index
cognitive function
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with Parkinsonism; two of them(tremor, akinesia, rigidity, postural instability), and showed gradual disease progression
Key exclusion criteria
ICD or Pacemaker implanted patients
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Mihara |
Organization
Kawasaki Medical School
Division name
Department of Neurology
Zip code
701-0192
Address
577 Matsushima, Kurashiki-City,Okayama,701-0192, JAPAN
TEL
086-462-1111
mihara@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Mihara |
Organization
Kawasaki Medical School
Division name
Department of Neurology
Zip code
701-0192
Address
577 Matsushima, Kurashiki-City,Okayama,701-0192, JAPAN
TEL
086-462-1111
Homepage URL
mihara@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review board, Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama,701-0192
Tel
11
qqq@wwwwwww
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
| 2017 | Year | 09 | Month | 15 | 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
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
planning to merge with other cohort
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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
cognitive and motor assessment were performed every 2 years.
Management information
Registered date
| 2017 | Year | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032409
