NCT01492686已完成3 期
Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
Shionogi1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2011年12月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
研究概览
简要总结
The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the ALS patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic criteria El Escorial and revised Airlie House.
- •Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
- •Patients of less than 2 years after the onset of ALS.
- •Patients whose progress of the condition during 12 weeks before administration meet other requirements.
排除标准
- •Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
- •Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
- •Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
- •In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
研究组 & 干预措施
Arm 1
Experimental
干预措施: MCI-186 in open label phase (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
Arm 2
Placebo Comparator
干预措施: MCI-186 in open label phase (Drug)
Arm 1
Experimental
干预措施: MCI-186 (Drug)
结局指标
主要结局
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
时间窗: baseline and 24 weeks
0=worst; 48=best
次要结局
- Number of Participants With Death or a Specified State of Disease Progression(24 weeks)
- Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks(baseline and 24 weeks)
- Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks(baseline and 24 weeks)
- Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks(baseline and 24 weeks)
- Percentage of Participants With Adverse Events(24 weeks)
- Percentage of Participants With Adverse Drug Reactions(24 weeks)
- Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)(24 weeks)
- Percentage of Participants With Abnormal Values in Sensory Examinations(baseline and 24 weeks)
研究者
研究点 (1)
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