NCT02287064Unknown1 期
An Open-label Trial of Intravenous Immune Globulin (IVIG)in Treating Spinocerebellar Ataxias
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in Scale for the Assessment and Rating Ataxia (SARA)
研究概览
简要总结
The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6, 10 and 11.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with SCA types 1, 2, 3, 6, 10, or 11, diagnosed by a movement disorder specialist.
- •Age 18 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.
- •Diagnosis of peripheral neuropathy. See exclusion criteria 3 for specific types of peripheral neuropathy to be excluded.
- •Throughout the study, all possible efforts will be made to maintain subject levels of activity, exercise or physical therapy.
- •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 diabetes (as determined by blood glucose labs within the past 6 months), nutritional deficiency causing neuropathy (vitamin B1, 3, 6, and 12 or vitamin E), injuries, autoimmune disorders (HIV, lupus, pediatric Guillain-Barre syndrome, neurosarcoidosis, monoclonal gammopathy), tumors, infections (leprosy), exposures to toxins (alcohol, arsenic, mercury), thyroid disease or hereditary causes (cerebral amyloid angiopathy) known to result in the presence of peripheral neuropathy.
- •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 (as evidenced by labs reported within the past 6 months).
- •Clinically significantly abnormal white blood cell count, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
- •Immunoglobulin A, Vitamin B (1, 3, 6, or 12), vitamin E or folate deficiencies (evidenced by screening lab evaluations).
研究组 & 干预措施
Intravenous Immune Globulin (IVIG)
Experimental
干预措施: Intravenous Immune Globulin (IVIG) (Drug)
结局指标
主要结局
Changes in Scale for the Assessment and Rating Ataxia (SARA)
时间窗: Will be assesed at abseline, day 14, day28 and day 56.
The primary outcomes will be the changes in the patient's SARA total score and frequency and severity of adverse events.
次要结局
- clinician and patient global impression of improvement (CGI and PGI)(Will be assesed at abseline, day 14, day28 and day 56.)
- Neurologic dysfunction as assessed by STAND scores(Will be assesed at abseline, day 14, day28 and day 56.)
- 9-hole peg test(Will be assesed at abseline, day 14, day28 and day 56.)
研究者
研究点 (1)
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