UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037846 |
|---|---|
| Receipt number | R000043148 |
| Scientific Title | The studies for building up of database of natural history of spinocerebellar ataxia type 1 |
| Date of disclosure of the study information | 2019/08/29 |
| Last modified on | 2021/08/30 09:17:04 |
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Basic information
Public title
The studies for building up of database of natural history of spinocerebellar ataxia type 1
Acronym
Natural history of SCA1
Scientific Title
The studies for building up of database of natural history of spinocerebellar ataxia type 1
Scientific Title:Acronym
Natural history of SCA1
Region
| Japan |
Condition
Condition
Spinocerebellar ataxia type 1
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Building up the database of natural history of spinocerebellar ataxia type 1.
Basic objectives2
Others
Basic objectives -Others
Building up the database of natural history.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARA, quantitative analysis of gait ataxia, and 9-hole peg test every 24 weeks. Blood flow of cerebellum and brain MRI findings every 48 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who are definite diagnosed as SCA1 and who can walk for 6 minutes independently.
Key exclusion criteria
The patients who are younger than 20 years old or lacking a capacity for judgement because of cognitive impairment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yabe |
Organization
Hokkaido University Hospital
Division name
The department of Neurology
Zip code
060-8648
Address
Kita 14 Nishi 5, Kita-ku, Sapporo city.
TEL
011-706-6028
yabe@med.hokkudai.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Shirai |
Organization
Hokkaido University Hospital
Division name
The department of Neurology
Zip code
060-8648
Address
Kita 14 Nishi 5, Kita-ku, Sapporo city.
TEL
011-706-6028
Homepage URL
shirai@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
Kita 14 Nishi 5, Kita-ku, Sapporo city.
Tel
0117066028
shirai@med.hokudai.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 29 | 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
| 2017 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study.
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043148
