UMIN-CTR Clinical Trial

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
Email	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
Email	shirai@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043148