Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
| Condition | Amyotrophic Lateral Sclerosis |
|---|---|
| Phase | Phase 3 |
| Sponsor | Shionogi |
| Status | Completed |
| Enrollment | 137 participants |
| Interventions | MCI-186, MCI-186 in open label phase |
| Start date | Dec 31, 2011 |
| Completion date | Sep 30, 2014 |
| Results posted | Dec 31, 2018 |
Summary
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 |
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
- Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) — 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