Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
研究概览
简要总结
Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).
详细描述
Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS). This clinical trial is open-label, single group and before and after comparison study. Dosage of lacosamide is increased from 100mg to 400mg for 4 weeks. Safety of lacosamide administration in ALS is primary endpoint. Nerve excitability, fasciculation and muscle cramp are investigated before and after administration for secondary endpoints.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 20 year old
- •Probable or definite ALS disease evaluated by Awaji electrophysiological criteria
- •Subjects provided informed consent.
排除标准
- •Patient without ability to comprehend informed consent
- •Patient with uncompensated medical illness
- •Patient with cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.)
- •Patient with arrhythmia (incomplete atrioventricular block and bundle branch block etc.)
- •Patient with sodium channel disorders, such as Brugada syndrome
- •Patient already administered anti-arrhythmic drug which prolongs PR interval (interval between arterial and ventral contraction measured by ECG)
- •Pregnant or breast-feeding woman
- •Patient with forced vital capacity of < 60% predicted
- •Patient already performed tracheotomy or tube feeding
- •Patient who takes any other experimental agents 3 months before.
- •Not enough compound muscle action potential amplitude in the median nerve to be performed nerve excitability test
- •Patient who plans to change medicine which affects nerve excitability during this trial 4 weeks
- •Familial ALS
- •Patient who is judged inappropriate for this trail by doctors responsible for this trial
研究组 & 干预措施
Lacosamide
干预措施: Lacosamide (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
时间窗: 4 weeks
Adverse events will be observed at each visit by direct questioning of the subjects, clinical examination, electrocardiogram (ECG), vital signs, vital capacity and laboratory test results.
次要结局
- Frequency of fasciculation(Baseline, Week 2 and Week 4)
- Frequency and extent of muscle cramp(Baseline, Week 2 and Week 4)
- Effects on strength-duration time constant(Baseline, Week 2 and Week 4)
- Effects on 0.2ms threshold change(Baseline, Week 2 and Week 4)
- Effects on threshold electrotonus(Baseline, Week 2 and Week 4)
- Effects on recovery cycle(Baseline, Week 2 and Week 4)
研究者
Satoshi Kuwabara
Professor
Chiba University