Phase 3
N=137
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS)
Bottom Line
View on ClinicalTrials.gov: NCT01492686 ↗Enrolled (actual)
137
Serious AEs
25.8%
Results posted
Dec 2018
Primary outcome: 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 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MCI-186 (Drug); Placebo (Drug); MCI-186 in open label phase (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Sep 2014
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 | — |
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.
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). 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.