Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
| 대상 질환 | Amyotrophic Lateral Sclerosis |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | Shionogi |
| 상태 | 완료 |
| 참여자 수 | 206 명 |
| 중재(약물) | MCI-186, Placebo of MCI-186 |
| 시작일 | 2006년 5월 31일 |
| 완료일 | 2008년 9월 30일 |
| 결과 공개일 | 2017년 5월 17일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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