UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046131
Receipt No. R000052655
Scientific Title A Randomized Parallel-Group Study to Evaluate the Efficacy and Safety of I mmunotherapy for Idiopathic Cerebellar Ataxia
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Randomized Parallel-Group Study to Evaluate the Efficacy and Safety of I mmunotherapy for Idiopathic Cerebellar Ataxia
Acronym A Randomized Parallel-Group Study to Evaluate the Efficacy and Safety of I mmunotherapy for Idiopathic Cerebellar Ataxia
Scientific Title A Randomized Parallel-Group Study to Evaluate the Efficacy and Safety of I mmunotherapy for Idiopathic Cerebellar Ataxia
Scientific Title:Acronym A Randomized Parallel-Group Study to Evaluate the Efficacy and Safety of I mmunotherapy for Idiopathic Cerebellar Ataxia
Region
Japan

Condition
Condition idiopathic cerebellar ataxia
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Evaluate the Efficacy and Safety of immunotherapy for Idiopathic Cerebellar Ataxia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in SARA scores between the baseline and week 4.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 early treatment group: steroid pulse therapy (methylprednisolone 1000 mg/day) at week 1 and week 3.
Interventions/Control_2 delayed treatment group: steroid pulse therapy (methylprednisolone 1000 mg/dose) at weeks 5 and 7.
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -30 years old and over (at the time of obtaining consent)
- idiopathic cerebellar ataxia according to the diagnostic criteria of the Ataxia Research Group of the Ministry of Health, Labour, and Welfare. (Note that "bilateral cerebellar atrophy on head CT and MRI" need not be met in this study.)
- Solitary case (the definition of the solitary case follows the criteria for idiopathic cerebellar ataxia)
- A slowly progressive course of events (a history of cerebellar ataxia of at least one year from onset to visit)
- seropositivity for the anti-cerebellar antibodies (confirmed by immunohistochemistry of rat brain section)
- Positive immunohistological serum anti-cerebella r antibodies
- Able to walk with a cane or by oneself at the time of obtaining consent
- SARA score of 5 or more at the time of consent
Key exclusion criteria - already included in another trial which includes any intervention study
- Those with a confirmed genetic diagnosis of hereditary spinocerebellar degeneration or those with a strong suspicion of hereditary origin
- Those with a history of alcoholism or drug abuse - Use of medications that are likely to cause lightheadedness or cerebellar ataxia at the time of consent (e.g., antiepileptic drugs, benzodiazepines)
- Those who are mentally disabled at the time of obtaining consent
- Previous or currently treated stomach ulcers
- Untreated or poorly controlled diabetes at the time of consent
- Persons with severe hepatic or renal impairment at the time of obtaining consent
- If you are pregnant or hoping to become pregnant at the time of obtaining consent
- Dementia at the time of consent
- At the time of obtaining consent, the patient is taking steroids or immunosuppressive drugs
- Those taking antiplatelet or anticoagulant drugs that cannot be stopped at the time of obtaining consent
- At the time of obtaining consent, the patient has an infectious disease that may be aggravated by steroids
- Other items deemed inappropriate by the principal investigator/associate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Nobuaki
Middle name
Last name Yoshikura
Organization Gifu University Hospital
Division name Department of Neurology
Zip code 501-1193
Address Gifu Univ ersity Graduate School of Medicine, Gifu, 1-1 Yan agido, Gifu 501-1194, Japan
TEL 058-230-6000
Email ny1113@gifu-u.ac.jp

Public contact
Name of contact person
1st name Nobuaki
Middle name
Last name Yoshikura
Organization Gifu University Hospital
Division name Department of Neurology
Zip code 501-1193
Address Gifu Univ ersity Graduate School of Medicine, Gifu, 1-1 Yan agido, Gifu 501-1194, Japan
TEL 058-230-6000
Homepage URL
Email ny1113@gifu-u.ac.jp

Sponsor
Institute Department of Neurology, Gifu University Hospital
Institute
Department

Funding Source
Organization Department of Neurology, Gifu University Hospital
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 Shinshu University Certified Review Board of Clinical Research
Address 3-1-1 asahi, matsumoto-shi, Nagano, Japan, Nagano
Tel 0263-37-2572
Email md_rinri@shinshu-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs031200250
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 24 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
2021 Year 01 Month 01 Day
Date of IRB
2020 Year 11 Month 09 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 20 Day
Last modified on
2021 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052655

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.