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Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Clinical Trials | Clareo Health

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

An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)

NCT00424463•Tanabe Pharma Corporation

View on ClinicalTrials.gov

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-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.

Eligibility

Age

20 - No limit years

Sex

ALL

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.

Locations (1)

National Hospital Organization Miyagi National Hospital

Watari-gun, Miyagi, Japan

Key Dates

Start Date

January 1, 2007

Primary Completion Date

May 1, 2009

Completion Date

May 1, 2009

Last Updated

January 6, 2026

Enrollment

181

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

MCI-186

DRUG

Placebo of MCI-186

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

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