An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 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 this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients who met severity classification III.
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 who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
- •Patients who cannot take at least one action of eating a meal, excreting, or moving with oneself alone, and need assistance in everyday life.
- •Patients whose progress of the condition during 12 weeks before administration meet other requirements.
排除标准
- •Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, sever heart disease, sever renal disease and so on, or they need to be administered antibiotics to infection.
- •Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
- •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 been administered other investigational products 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
2
干预措施: Placebo of MCI-186 (Drug)
1
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
No primary endpoint was used, because various exploratory analyses were performed. 0=worst; 48=best
Death or a Specified State of Disease Progression
时间窗: 24 weeks
No primary endpoint was used, because various exploratory analyses were performed. Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.
Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
时间窗: baseline and 24 weeks
No primary endpoint was used, because various exploratory analyses were performed.
The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients
时间窗: 24 weeks
No primary endpoint was used, because various exploratory analyses were performed.
Percentage of Participants With Adverse Events
时间窗: 24 weeks
No primary endpoint was used, because various exploratory analyses were performed.
Percentage of Participants With Abnormal Changes in Sensory Examinations
时间窗: 24 weeks
No primary endpoint was used, because various exploratory analyses were performed.
Percentage of Participants With Adverse Drug Reactions
时间窗: 24 weeks
No primary endpoint was used, because various exploratory analyses were performed.
次要结局
未报告次要终点