NCT02479802已完成2 期
Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
研究概览
简要总结
Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5% albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic Lateral Sclerosis (ALS).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written-informed consent.
- •Subjects over 18 years of age, and less than 70 years old.
- •Subjects with a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria.
- •Subjects having experienced their first ALS symptoms within 18 months before recruitment/consent.
- •FVC > 70%
- •Subjects must be medically suitable for study participation and of complying with all planned aspects of the protocol including blood sampling at the time of inclusion in the study.
排除标准
- •Subjects with a clinically significant preexisting lung disease not attributable to ALS.
- •Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
- •Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
- •Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
- •Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
- •Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team
- •A history of frequent adverse reactions (serious or otherwise) to blood products.
- •Hypersensitivity to albumin or allergies to any of the components of Albutein.
- •Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoagulants
- •Plasma creatinine > 2mg/dl.
- •Present a history of heart disease including ischemic heart disease or congestive heart failure.
- •Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
- •Any condition that complicates adherence to study protocol (illness with less than one year of expected survival, drug or alcohol abuse, etc.)
研究组 & 干预措施
Albumin
Experimental
Plasma exchange with Albumin
干预措施: Albumin (Biological)
结局指标
主要结局
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
时间窗: Baseline, Weeks 4, 12, 25, 36, and 48
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
时间窗: Baseline, Weeks 4, 12, 25, 36, and 48
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) includes 12 questions classified into 3 subdomains: bulbar function (3 questions), fine and gross motor skills (6 questions), and respiratory function (3 questions) to assess the level self sufficiency. Each task was graded according to a 5-point scale from 0 (incapable) to 4 (normal ability) with a total score from 0 (worst) to 48 (best).
次要结局
- Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).(Baseline, Weeks 25 and 48)
- Percentage of Plasma Exchange Sessions Associated With One Adverse Event or Adverse Reaction, Including Clinically Significant Changes in Vital Signs or Lab Parameters(During the Treatment Phase (24 weeks))
- Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle(Baseline, Weeks 4, 12, 25, 36, and 48)
- Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test(Baseline, Weeks 25 and 48)
研究者
研究点 (1)
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