UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047659 |
|---|---|
| Receipt number | 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 | 2023/05/06 11:06:24 |
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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
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/
ishizukatakami@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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、千葉大学（千葉県）/Chiba University、岐阜大学（岐阜県）/Gifu University、鹿児島大学（鹿児島県）/Kagoshima University、笛吹中央病院（山梨県）/Fuefuki Central Hospital、横浜市立大学（神奈川県）/Yokohama City University、近畿大学（大阪府）/Kindai University、鳥取大学（鳥取県）/Tottori University、北海道大学（北海道）/Hokkaido University、信州大学（長野県）/Shinshu University、群馬大学（群馬県）/Gunma University、名古屋大学（愛知県）/Nagoya University、東京大学（東京都）/The University of Tokyo、東京慈恵会医科大学（東京都）/The Jikei University、東京医科歯科大学（東京都）/Tokyo Medical and Dental University、大阪大学（大阪府）/Osaka University、焼津市立総合病院（静岡県）/Yaizu City Hospital
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 04 | Day |
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
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054255
| Research Plan | |
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| 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 |
