NCT01350440已完成2 期
Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Scale for the Assessment and Rating of Ataxia
研究概览
简要总结
This is a preliminary study to determine the safety and efficacy of intravenous immune globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in clinical measures of disease severity before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with SCA diagnosed by a movement disorder specialist.
- •Age 10 years to 80 years.
- •Able to ambulate with or without assistance for 30 feet.
- •Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
- •Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG do not reveal clinically significant abnormalities (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).
- •Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
- •Stable doses of all antidepressants and vitamins (including internet purchased idebenone) for 30 days prior to study entry and for the duration of the study. Throughout the study, all possible efforts should be made to maintain stable doses of all other medications.
- •Subject permission (informed consent).
排除标准
- •Any unstable illness that in the investigator's opinion precludes participation in this study.
- •Use of any investigational product within the past 30 days.
- •Presence of clinically significant cardiac disease (as determined by the investigator based on EKG and echocardiogram results within the past 6 months). Specifically, an ejection fraction <40%, or a prolonged QT interval (>50% of cycle duration) will be excluded. If the investigator notes clinically significant abnormalities on the EKG or echocardiogram, the subject will be eligible IF they provide clearance from a cardiologist.
- •Presence of diabetes (as determined by blood glucose labs within the past 6 months).
- •Dementia or other psychiatric illness that prevents the subject from giving informed consent (MMSE less than 25).
- •Legal incapacity or limited legal capacity.
- •Presence of severe renal disease (estimated creatinine clearance <50 mL/min) or hepatic disease (AST or ALT>2x times normal) (as evidenced by labs reported within the past 6 months).
- •Clinically significantly abnormal WBC, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
- •IgA deficiency (evidenced by screening lab evaluations)
结局指标
主要结局
Scale for the Assessment and Rating of Ataxia
时间窗: participants will be followed for approximately 4 months
次要结局
- Timed 25 foot walk(participants will be followed for approximately 4 months)
- Clinical Global impression(participants will be followed for approximately 4 months)
- Biodex Balance SD(participants will be followed for approximately 4 months)
- Gait Rite Mat(participants will be followed for approximately 4 months)
- Berg balance scale(participants will be followed for approximately 4 months)
- Complete Metabolic Panel(participants will be followed for approximately 4 months)
- Complete Blood Count(participants will be followed for approximately 4 months)
研究者
Theresa Zesiewicz
Professor of Neurology
University of South Florida
研究点 (2)
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