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

NCT00424463 | Completed Phase 3 Results

• 1 other identifier: MCI186-17
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic lateral sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

  0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.

  baseline (seventh cycle) and at 24 week (twelfth cycle)

Secondary Outcomes (6)

• Number of Participants With Death or a Specified State of Disease Progression

  24 weeks (from seventh cycle to twelfth cycle)

• Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

  baseline (seventh cycle) and at 24 week (twelfth cycle)

• Percentage of Participants With Adverse Events

  36 weeks (from seventh cycle to fifteenth cycle)

• Percentage of Participants With Adverse Drug Reactions

  36 weeks (from seventh cycle to fifteenth cycle)

• Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group

  36 weeks (from seventh cycle to fifteenth cycle)

Study Arms (2)

1

EXPERIMENTAL

Drug: MCI-186

2

PLACEBO COMPARATOR

Drug: Placebo of MCI-186

Interventions

MCI-186 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.

Also known as: Edaravone, Radicut

1

Placebo of MCI-186 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.

2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

National Hospital Organization Miyagi National Hospital

Watari-gun, Miyagi, Japan

Location

Related Publications (2)

• WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 17 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):20-31. doi: 10.1080/21678421.2017.1362000.

  PMID: 28872918 RESULT

• Takahashi F, Takei K, Tsuda K, Palumbo J. Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):32-39. doi: 10.1080/21678421.2017.1361442.

  PMID: 28872914 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Edaravone

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Koji Abe, professor

  Graduate School of Medicine and Dentistry, Okayama University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 19, 2007
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 6, 2026
• Results First Posted: June 4, 2018

Record last verified: 2025-12

Locations

JP (1)