A Randomized Parallel-Group Study to Evaluate the Efficacy and Safety of Immunotherapy for Idiopathic Cerebellar Ataxia

Yoshikura Nobuaki0 个研究点目标入组 20 人开始时间: 2020年12月16日最近更新: 2024年5月27日

适应症

试验速览

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•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-cerebellar 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

•- 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

发起方

Yoshikura Nobuaki