Status:
COMPLETED
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blin...
Eligibility Criteria
Inclusion
- Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00424463
Start Date
January 1 2007
End Date
May 1 2009
Last Update
January 6 2026
Active Locations (1)
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1
National Hospital Organization Miyagi National Hospital
Watari-gun, Miyagi, Japan