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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047659
Receipt No. R000054255
Scientific Title Historical data collection with J-CAT and J-CAT PRIME for pure cerebellar type spinocerebellar degeneration
Date of disclosure of the study information 2022/05/09
Last modified on 2022/05/06

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Basic information
Public title Historical data collection with J-CAT and J-CAT PRIME for pure cerebellar type spinocerebellar degeneration
Acronym J-CAT PRIME
Scientific Title Historical data collection with J-CAT and J-CAT PRIME for pure cerebellar type spinocerebellar degeneration
Scientific Title:Acronym J-CAT PRIME
Region
Japan

Condition
Condition spinocerebellar degeneration
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate etiology and pathomechanism of spinocerebellar degeneration, and research and development for new therapies.
Basic objectives2 Others
Basic objectives -Others To collect clinical information of spinocerebellar degeneration patients in a sustained manner for a long time period, and to utilize the registry data for pharmaceuticals development.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes SARA
mRS
Flow-FIM
Key secondary outcomes

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 1. written consent form of patient for entry into the registry is available
2. patient over 18 years old
3. patients with spinocerebellar ataxia type 6 (SCA6) or spinocerebellar ataxia type 31 (SCA31) and registered in J-CAT
Key exclusion criteria 1. Patients with dementia
2. Determined by investigators to be ineligible to participate in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hidehiro
Middle name
Last name Mizusawa
Organization National Center of Neurology and Psychiatry
Division name The board of directors
Zip code 187-8551
Address 4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan
TEL 0423412711
Email mizusawa@ncnp.go.jp

Public contact
Name of contact person
1st name Takami
Middle name
Last name Ishizuka
Organization National Center of Neurology and Psychiatry
Division name Section of Clinical Research Support, Clinical Research and Education Promotion Division
Zip code 187-8551
Address 4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan
TEL 0423412711
Homepage URL http://jcat.umin.ne.jp/
Email ishizukatakami@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization KISSEI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center of Neurology and Psychiatry
Address 4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan
Tel 042-341-2711
Email ml_rinrijimu@ncnp.go.jp

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 新潟大学(新潟県)/Niigata University

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 09 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 Preinitiation
Date of protocol fixation
2022 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2022 Year 05 Month 31 Day
Last follow-up date
2027 Year 01 Month 31 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 05 Month 06 Day
Last modified on
2022 Year 05 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054255

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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