Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
| Заболевание | Amyotrophic Lateral Sclerosis |
|---|---|
| Фаза | Фаза 3 |
| Спонсор | Shionogi |
| Статус | Завершено |
| Участники | 137 участн. |
| Вмешательство | MCI-186, MCI-186 in open label phase |
| Дата начала | 31.12.2011 |
| Дата завершения | 30.09.2014 |
| Публикация результатов | 31.12.2018 |
Кратко
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 |
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