NCT01492686CompletedPhase 3
Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
Shionogi1 site in 1 country137 target enrollmentStarted: December 31, 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Arm 1
Experimental
Intervention: MCI-186 in open label phase (Drug)
Arm 2
Placebo Comparator
Intervention: Placebo (Drug)
Arm 2
Placebo Comparator
Intervention: MCI-186 in open label phase (Drug)
Arm 1
Experimental
Intervention: MCI-186 (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
Time Frame: baseline and 24 weeks
0=worst; 48=best
Secondary Outcomes
- Number of Participants With Death or a Specified State of Disease Progression(24 weeks)
- Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks(baseline and 24 weeks)
- Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks(baseline and 24 weeks)
- Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks(baseline and 24 weeks)
- Percentage of Participants With Adverse Events(24 weeks)
- Percentage of Participants With Adverse Drug Reactions(24 weeks)
- Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)(24 weeks)
- Percentage of Participants With Abnormal Values in Sensory Examinations(baseline and 24 weeks)
Investigators
Study Sites (1)
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