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

NCT00415519 | Completed Phase 3 Results

• 1 other identifier: MCI186-18
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients who met severity classification III.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic lateral sclerosis; free radical scavenger

Outcome Measures

Primary Outcomes (7)

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

  No primary endpoint was used, because various exploratory analyses were performed. 0=worst; 48=best

  baseline and 24 weeks

• Death or a Specified State of Disease Progression

  No primary endpoint was used, because various exploratory analyses were performed. Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.

  24 weeks

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

  No primary endpoint was used, because various exploratory analyses were performed.

  baseline and 24 weeks

• Percentage of Participants With Adverse Events

  No primary endpoint was used, because various exploratory analyses were performed.

  24 weeks

• Percentage of Participants With Adverse Drug Reactions

  No primary endpoint was used, because various exploratory analyses were performed.

  24 weeks

• The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients

  No primary endpoint was used, because various exploratory analyses were performed.

  24 weeks

• Percentage of Participants With Abnormal Changes in Sensory Examinations

  No primary endpoint was used, because various exploratory analyses were performed.

  24 weeks

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 successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Also known as: Edaravone, Radicut

1

Placebo of MCI-186 DRUG

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

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 who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
• Patients who cannot take at least one action of eating a meal, excreting, or moving with oneself alone, and need assistance in everyday life.
• Patients whose progress of the condition during 12 weeks before administration meet other requirements.

You may not qualify if:

• Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, sever heart disease, sever renal disease and so on, or they need to be administered antibiotics to infection.
• Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
• 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 been administered other investigational products within 12 weeks before consent, or who are participating in other clinical trials at present.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Related Publications (1)

• WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 18 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation). Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):40-48. doi: 10.1080/21678421.2017.1361441.

  PMID: 28872915 RESULT

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

  PRINCIPAL INVESTIGATOR

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 22, 2006
• First Posted: December 25, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 6, 2026
• Results First Posted: December 20, 2017

Record last verified: 2025-12