Phase 3
Completed N=137
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS)
Source: ClinicalTrials.gov NCT01492686 ↗
Enrolled (actual)
137
Serious AEs
25.8%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — -5.01; -7.5 units on a scale
◆ Published Evidence
Highly cited
927citations · ~103 / year
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
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.
Linked Publications (5)
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Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
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Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.
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Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis.
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The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis.
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Real-world safety and tolerability of intravenous edaravone in patients with 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 |
-5.01; -7.5 | — |
| SECONDARY Number of Participants With Death or a Specified State of Disease Progression |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks |
-15.61; -20.4 | — |
| SECONDARY Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks |
-15.91; -20.8 | — |
| SECONDARY Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks |
17.25; 26.04 | — |
| SECONDARY Percentage of Participants With Adverse Events |
84.1; 83.8 | — |
| SECONDARY Percentage of Participants With Adverse Drug Reactions |
2.9; 7.4 | — |
| SECONDARY Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0) |
0; 1.5; 0; 1.5; 1.4; 1.5 | — |
| SECONDARY Percentage of Participants With Abnormal Values in Sensory Examinations |
2.9; 7.4; 7.2; 9.4; 1.4; 8.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic criteria El Escorial and revised Airlie House.
- Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
- Patients of less than 2 years after the onset of ALS.
- Patients whose progress of the condition during 12 weeks before administration meet other requirements.
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.
- Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
- Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
- 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 (NCT01492686) 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.