Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: MCI-186; Placebo of MCI-186
Intervention description: 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).; 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).
Intervention MeSH terms: Edaravone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Amyotrophic lateral sclerosis; free radical scavenger

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.