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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
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.)
结局指标
主要结局
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).
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
时间窗: Baseline, Weeks 4, 12, 25, 36, and 48
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 (2)
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