Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
| 适应症 | Amyotrophic Lateral Sclerosis |
|---|---|
| 分期 | 3期 |
| 申办方 | Shionogi |
| 状态 | 已完成 |
| 受试者人数 | 206 人 |
| 干预（药物） | MCI-186, Placebo of MCI-186 |
| 开始日期 | 2006年5月31日 |
| 完成日期 | 2008年9月30日 |
| 结果公布日 | 2017年5月17日 |
摘要
The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in 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. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
| MCI-186 | -5.7 ± 0.85 units on a scale |
|---|---|
| Placebo of MCI-186 | -6.35 ± 0.84 units on a scale |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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- Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — Shionogi
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