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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028752
Receipt No. 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 2019/02/20

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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
Middle name
Last name Masahito Mihara
Organization Kawasaki Medical School
Division name Department of Neurology
Zip code
Address 577 Matsushima, Kurashiki-City,Okayama,701-0192, JAPAN
TEL 086-462-1111
Email mihara@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahito Mihara
Organization Kawasaki Medical School
Division name Department of Neurology
Zip code
Address 577 Matsushima, Kurashiki-City,Okayama,701-0192, JAPAN
TEL 086-462-1111
Homepage URL
Email mihara@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
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
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032409

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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