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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006214
Receipt No. R000007351
Scientific Title The safety and efficacy of tartillerin in patints with SCD
Date of disclosure of the study information 2011/08/22
Last modified on 2011/08/22

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Basic information
Public title The safety and efficacy of tartillerin in patints with SCD
Acronym The safety and efficacy of tartillerin in patints with SCD
Scientific Title The safety and efficacy of tartillerin in patints with SCD
Scientific Title:Acronym The safety and efficacy of tartillerin in patints with SCD
Region
Japan

Condition
Condition spinocerebellar degeneration
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the treatment for the ataxia in patients with SCD by administration of Tartilerin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement of ataxia using SARA score or ICARS. Spiral drawing. Tapping test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of Tartillerin at dosage of 10mg daily
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with spinocerebellar degeneration
2)Patients with informed of consent
Key exclusion criteria Patient whom doctor judged to be undesirable as object of examination
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YOSHIYUKI KUROIWA
Organization Yokohama City University School of Medicine
Division name Neurology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name NAOHISA UEDA
Organization Yokohama City University School of Medicine
Division name Neurology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Neurology, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2011 Year 08 Month 22 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 Enrolling by invitation
Date of protocol fixation
2008 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 08 Month 01 Day
Date trial data considered complete
2012 Year 08 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 22 Day
Last modified on
2011 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007351

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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