UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046131 |
|---|---|
| Receipt number | 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 | 2024/05/23 09:13:15 |
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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
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
ny1113@gifu-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Gifu University Hospital
Institute
Department
Personal name
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
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
| 2028 | 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
| 2024 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052655
