UMIN-CTR Clinical Trial

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
Email	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
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	Research Ethics Review board, Kawasaki Medical School
Address	577 Matsushima, Kurashiki, Okayama,701-0192
Tel	11
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032409