Status:
COMPLETED
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional r...
Eligibility Criteria
Inclusion
- Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic criteria El Escorial and revised 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 2 years after the onset of ALS.
- Patients whose progress of the condition during 12 weeks before administration meet other requirements.
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.
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01492686
Start Date
December 1 2011
End Date
October 1 2014
Last Update
January 6 2026
Active Locations (1)
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1
Osaka, Japan