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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

NCT00330681

Amyotrophic Lateral Sclerosis (ALS)

COMPLETED PHASE3

Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

NCT01492686

Amyotrophic Lateral Sclerosis (ALS)

COMPLETED PHASE3

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

NCT00415519

Amyotrophic Lateral Sclerosis (ALS)

COMPLETED PHASE3

A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT00444613

Amyotrophic Lateral Sclerosis (ALS)

COMPLETED PHASE2/PHASE3

Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis

NCT04849065

ALS (Amyotrophic Lateral Sclerosis)

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyotrophic Lateral Sclerosis (ALS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

MCI-186

Intervention Type DRUG

Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.

2

Group Type PLACEBO_COMPARATOR

Placebo of MCI-186

Intervention Type DRUG

Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MCI-186

Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.

Intervention Type DRUG

Placebo of MCI-186

Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Edaravone Radicut

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No