Phase 3
Completed N=181
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Source: ClinicalTrials.gov NCT00424463 ↗
Enrolled (actual)
181
Serious AEs
42.5%
Results posted
Jun 2018
Primary outcomePrimary: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — -5.5; -4.2; -5.4 units on a scale
◆ Published Evidence
Established
43citations · ~5 / year
Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.
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.
Linked Publications (2)
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Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.
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Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks |
-5.5; -4.2; -5.4 | — |
| SECONDARY Number of Participants With Death or a Specified State of Disease Progression |
1; 1; 1; 8; 11; 20 | — |
| SECONDARY Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks |
-10.6; -12.91; -10.54 | — |
| SECONDARY Percentage of Participants With Adverse Events |
97.8; 91.7; 92 | — |
| SECONDARY Percentage of Participants With Adverse Drug Reactions |
4.4; 10.4; 10.2 | — |
| SECONDARY Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group |
11.1; 4.2; 10.2; 0; 6.3; 4.5 | — |
| SECONDARY Percentage of Participants With Abnormal Changes in Sensory Examinations |
0; 0; 0; 0; 2.1; 2.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.
Exclusion Criteria
- Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
- Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681.
- Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
- Patients who are participating in other clinical trials except the study NCT00330681.
- In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
Data sourced from ClinicalTrials.gov (NCT00424463) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.