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

NCT01492686 | Completed Phase 3 Results DMC

• 1 other identifier: MCI186-19
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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 rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the 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

  baseline and 24 weeks

Secondary Outcomes (8)

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

  24 weeks

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

  baseline and 24 weeks

• Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks

  baseline and 24 weeks

• Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks

  baseline and 24 weeks

• Percentage of Participants With Adverse Events

  24 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: MCI-186; Drug: MCI-186 in open label phase

Arm 2

PLACEBO COMPARATOR

Drug: Placebo; Drug: MCI-186 in open label phase

Interventions

MCI-186 DRUG

Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Arm 1

Placebo DRUG

Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Arm 2

MCI-186 in open label phase DRUG

All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.

Arm 1; Arm 2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

Related Publications (4)

• Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15.

  PMID: 28522181 RESULT

• WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 19 STUDY GROUP. Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):55-63. doi: 10.1080/21678421.2017.1364269.

  PMID: 28872920 RESULT

• Brooks BR, Pioro EP, Sakata T, Takahashi F, Hagan M, Apple S. The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis. Muscle Nerve. 2023 Oct;68(4):397-403. doi: 10.1002/mus.27946. Epub 2023 Jul 31.

  PMID: 37525592 DERIVED

• Takei K, Takahashi F, Liu S, Tsuda K, Palumbo J. Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):49-54. doi: 10.1080/21678421.2017.1361443.

  PMID: 28872913 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

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: December 11, 2011
• First Posted: December 15, 2011
• Study Start: December 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 6, 2026
• Results First Posted: December 31, 2018

Record last verified: 2025-12

Locations

JP (1)