Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
| 対象疾患 | Amyotrophic Lateral Sclerosis |
|---|---|
| 相 | 第3相 |
| スポンサー | Shionogi |
| ステータス | 完了 |
| 参加者数 | 137 名 |
| 介入（薬剤） | MCI-186, MCI-186 in open label phase |
| 開始日 | 2011年12月31日 |
| 完了日 | 2014年9月30日 |
| 結果公開日 | 2018年12月31日 |
概要
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 |
BENITIONS で見る ClinicalTrials.gov の原文を見る
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