Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Treatments

Drug: Placebo of MCI-186

Drug: MCI-186

Study type

Interventional

Funder types

Industry

Identifiers

NCT00424463

MCI186-17

Details and patient eligibility

About

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-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

Enrollment

181 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.