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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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12 December 2020 |
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Main ID: |
NCT00424463 |
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Date of registration:
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17/01/2007 |
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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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Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3) |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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181 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00424463 |
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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 ware completed drug administration without discontinuation in the
preceding confirmatory study NCT00330681.
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.
- Patients whose creatinine clearance is 50mL/min or less at the time of completion of
drug administration in the study NCT00330681.
- Pregnant, lactating, and probably pregnant patients, and patients who want to become
pregnant, and patients who can not agree to contraception.
- Patients who are participating in other clinical trials except the study NCT00330681.
- 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:
N/A
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: Placebo of MCI-186
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Drug: 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 (seventh cycle) and at 24 week (twelfth cycle)]
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Secondary Outcome(s)
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Number of Participants With Death or a Specified State of Disease Progression
[Time Frame: 24 weeks (from seventh cycle to twelfth cycle)]
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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: 36 weeks (from seventh cycle to fifteenth cycle)]
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Percentage of Participants With Abnormal Changes in Sensory Examinations
[Time Frame: 36 weeks (from seventh cycle to fifteenth cycle)]
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Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
[Time Frame: baseline (seventh cycle) and at 24 week (twelfth cycle)]
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Percentage of Participants With Adverse Events
[Time Frame: 36 weeks (from seventh cycle to fifteenth cycle)]
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Percentage of Participants With Adverse Drug Reactions
[Time Frame: 36 weeks (from seventh cycle to fifteenth cycle)]
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Secondary ID(s)
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MCI186-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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