NCT03489200已完成不适用
EH301 for the Treatment of Amyotrophic Lateral Sclerosis: a Placebo-Controlled Study
Elysium Health1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- ALSFRS-r
研究概览
简要总结
The objective of this trial is to evaluate the efficacy and tolerability of EH301 in patients with amyotrophic lateral sclerosis. Patients with ALS are randomized to receive either EH301 or placebo daily and undergo active evaluation for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Diagnosis of probable or definite (sporadic or familial) ALS by El Escorial criteria
- •Onset of symptomatology for more than 6 months
- •If female: not lactating; negative pregnancy test; agree to use an effective method of birth control throughout study
排除标准
- •Tracheostomy, invasive ventilation, or non-invasive positive pressure ventilation
- •Gastrostomy
- •Evidence of major psychiatric disorder or clinically evident dementia
- •Diagnosis of a neurodegenerative disease in addition to ALS
- •Current medication apart from riluzole that in the opinion of the investigator would make the patient unsuitable for study participation
- •Recent history (within the previous 6 months) or current evidence of alcohol or drug abuse
- •Concurrent unstable disease involving any system (e.g. carcinoma other than basal cell carcinoma), any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of coronary artery disease, or any other condition that in the opinion of the investigator would make the patient unsuitable for study participation
- •Baseline QTc (Bazett) > 450 msec for males and > 470 msec for females
- •Known hepatitis B/C or HIV positive serology
- •Renal impairment defined as blood creatinine > 2x ULN
- •Hepatic impairment and/or liver enzymes (ALT or AST) > 3x ULN
- •Hemostasis disorders or current treatment with oral anticoagulants
- •Participated in any other investigational drug or therapy study with a non-approved medication, within the previous 3 months
- •No medical insurance
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
EH301
Experimental
干预措施: EH301 (Other)
结局指标
主要结局
ALSFRS-r
时间窗: 6 months
ALS Functional Rating Scale - revised score is a summation of ratings across across fine and gross motor, bulbar and respiratory functional domains. The scale ranges from 0-48, with higher total score representing better outcomes. The twelve subscales are rated on a five-point scale from 0 (can't do) to 4 (normal ability) and combined to compute the total score. This outcome measures change observed from baseline to 6 months.
次要结局
- MRC(6 months)
- Anthropometry(6 months)
- FVC(6 months)
- Electromyogram(6 months)
研究者
研究点 (1)
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