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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00330681 |
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Date of registration:
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26/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner. |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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206 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00330681 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Koji Abe, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Graduate School of Medicine and Dentistry, Okayama University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis (ALS)
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Intervention(s)
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Drug: MCI-186
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Drug: Placebo of MCI-186
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
[Time Frame: baseline and 24 weeks]
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Percentage of Participants With Adverse Drug Reactions
[Time Frame: 24 weeks]
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Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
[Time Frame: 24 weeks]
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Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks
[Time Frame: baseline and 24 weeks]
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Death or a Specified State of Disease Progression
[Time Frame: 24 weeks]
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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]
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Percentage of Participants With Abnormal Changes in Sensory Examinations
[Time Frame: 24 weeks]
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Percentage of Participants With Adverse Events
[Time Frame: 24 weeks]
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Secondary ID(s)
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MCI186-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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