Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

Фаза 3 Завершено NCT00415519

Кратко

The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, 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 who met severity classification III.

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

baseline and 24 weeks · units on a scale

Death or a Specified State of Disease Progression

24 weeks · events

Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

baseline and 24 weeks · percentage of FVC

Открыть в BENITIONS Открыть на ClinicalTrials.gov

Другие исследования по этому заболеванию

• Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Ed — Shionogi
• Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic L — Shionogi
• Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — Shionogi
• Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis — Shionogi
• Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS — Shionogi
• Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral — Shionogi

Все исследования