Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
| Заболевание | Amyotrophic Lateral Sclerosis |
|---|---|
| Фаза | Фаза 3 |
| Спонсор | Shionogi |
| Статус | Завершено |
| Участники | 206 участн. |
| Вмешательство | MCI-186, Placebo of MCI-186 |
| Дата начала | 31.05.2006 |
| Дата завершения | 30.09.2008 |
| Публикация результатов | 17.05.2017 |
Кратко
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 |
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