Phase 3
N=181
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Bottom Line
View on ClinicalTrials.gov: NCT00424463 ↗Enrolled (actual)
181
Serious AEs
42.5%
Results posted
Jun 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 — -5.5; -4.2; -5.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MCI-186 (Drug); Placebo of MCI-186 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- May 2009
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 | — |
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.
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). 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.