Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
| 适应症 | Amyotrophic Lateral Sclerosis |
|---|---|
| 分期 | 3期 |
| 申办方 | Shionogi |
| 状态 | 已完成 |
| 受试者人数 | 137 人 |
| 干预（药物） | MCI-186, MCI-186 in open label phase |
| 开始日期 | 2011年12月31日 |
| 完成日期 | 2014年9月30日 |
| 结果公布日 | 2018年12月31日 |
摘要
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.
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
| MCI-186 | -5.01 ± 0.64 units on a scale |
|---|---|
| Placebo of MCI-186 | -7.5 ± 0.66 units on a scale |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
同一适应症的其他试验
- Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Ed — Shionogi
- Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic L — Shionogi
- Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — Shionogi
- Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — Shionogi
- Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS — Shionogi
- Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral — Shionogi