Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
| Condition | Amyotrophic Lateral Sclerosis |
|---|---|
| Phase | Phase 3 |
| Sponsor | Shionogi |
| Status | Completed |
| Enrollment | 181 participants |
| Interventions | MCI-186, Placebo of MCI-186 |
| Start date | Jan 31, 2007 |
| Completion date | May 31, 2009 |
| Results posted | Jun 4, 2018 |
Summary
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 |
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
- Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — 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