Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
| 대상 질환 | Amyotrophic Lateral Sclerosis |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | Shionogi |
| 상태 | 완료 |
| 참여자 수 | 181 명 |
| 중재(약물) | MCI-186, Placebo of MCI-186 |
| 시작일 | 2007년 1월 31일 |
| 완료일 | 2009년 5월 31일 |
| 결과 공개일 | 2018년 6월 4일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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