An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 2
- 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
This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.
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.
- •Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT
- •Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
- •Patients who are participating in other clinical trials except the study NCT
- •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 (seventh cycle) and at 24 week (twelfth cycle)
0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.
次要结局
- Number of Participants With Death or a Specified State of Disease Progression(24 weeks (from seventh cycle to twelfth cycle))
- Percentage of Participants With Adverse Drug Reactions(36 weeks (from seventh cycle to fifteenth cycle))
- Percentage of Participants With Adverse Events(36 weeks (from seventh cycle to fifteenth cycle))
- Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks(baseline (seventh cycle) and at 24 week (twelfth cycle))
- Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group(36 weeks (from seventh cycle to fifteenth cycle))
- Percentage of Participants With Abnormal Changes in Sensory Examinations(36 weeks (from seventh cycle to fifteenth cycle))