Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
| Condition | Amyotrophic Lateral Sclerosis |
|---|---|
| Phase | Phase 3 |
| Sponsor | Shionogi |
| Status | Completed |
| Enrollment | 206 participants |
| Interventions | MCI-186, Placebo of MCI-186 |
| Start date | May 31, 2006 |
| Completion date | Sep 30, 2008 |
| Results posted | May 17, 2017 |
Summary
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 |
Open in BENITIONS View on ClinicalTrials.gov
Other trials for this condition
- 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