Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
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|ClinicalTrials.gov Identifier: NCT00330681|
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Drug: MCI-186 Drug: Placebo of MCI-186||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
Placebo Comparator: 2
Placebo of MCI-186
Drug: Placebo of MCI-186
Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
- 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 ]ALSFRS-R Score: 0=worst; 48=best
- Death or a Specified State of Disease Progression [ Time Frame: 24 weeks ]Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.
- Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
- Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102
- Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40
- Percentage of Participants With Adverse Events [ Time Frame: 24 weeks ]
- Percentage of Participants With Adverse Drug Reactions [ Time Frame: 24 weeks ]
- Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group [ Time Frame: 24 weeks ]
- Percentage of Participants With Abnormal Changes in Sensory Examinations [ Time Frame: 24 weeks ]
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|Ages Eligible for Study:||20 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330681
|Study Chair:||Koji Abe, professor||Graduate School of Medicine and Dentistry, Okayama University|
|Responsible Party:||Mitsubishi Tanabe Pharma Corporation|
|Other Study ID Numbers:||
|First Posted:||May 29, 2006 Key Record Dates|
|Results First Posted:||May 17, 2017|
|Last Update Posted:||May 17, 2017|
|Last Verified:||April 2017|
Amyotrophic lateral sclerosis
free radical scavenger
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs