Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With 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 | 181 人 |
| 干预（药物） | MCI-186, Placebo of MCI-186 |
| 开始日期 | 2007年1月31日 |
| 完成日期 | 2009年5月31日 |
| 结果公布日 | 2018年6月4日 |
摘要
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.
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
| MCI-186 - Placebo of MCI-186 | -5.5 ± 4.6 units on a scale |
|---|---|
| MCI-186 - MCI-186 | -4.2 ± 4 units on a scale |
| Placebo of MCI-186 - MCI-186 | -5.4 ± 4.5 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
- 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
- Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis — 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