Phase 3
N=206
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Bottom Line
View on ClinicalTrials.gov: NCT00330681 ↗Enrolled (actual)
206
Serious AEs
20.4%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — -5.7; -6.35 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
- Sep 2008
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 |
-5.7; -6.35 | — |
| SECONDARY Death or a Specified State of Disease Progression |
2; 2; 28; 23; 2; 4 | — |
| SECONDARY Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks |
-14.57; -17.49 | — |
| SECONDARY Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks |
-14.12; -16.15 | — |
| SECONDARY Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks |
19.6; 19.13 | — |
| SECONDARY Percentage of Participants With Adverse Events |
89.2; 88.5 | — |
| SECONDARY Percentage of Participants With Adverse Drug Reactions |
13.7; 19.2 | — |
| SECONDARY Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group |
2; 5.8; 6.9; 2.9 | — |
| SECONDARY Percentage of Participants With Abnormal Changes in Sensory Examinations |
1; 1; 2; 3.8; 0; 1 | — |
Summary
The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in 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. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.
Eligibility Criteria
Inclusion Criteria
- Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for 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 3 years after the onset of ALS.
- Patients whose progress of the condition during 12 weeks before administration meet other requirements.
Exclusion Criteria
- Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, severe heart disease, severe renal disease and so on, or they need to be administered antibiotics to infection.
- Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
- 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 (NCT00330681). 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.