Completed

NCT Number: NCT00415519

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Treatment and study plan

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).

Other names: Edaravone, Radicut

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).

Primary outcomes

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

Time frame: baseline and 24 weeks

No primary endpoint was used, because various exploratory analyses were performed. 0=worst; 48=best
Death or a Specified State of Disease Progression

Time frame: 24 weeks

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

Time frame: baseline and 24 weeks

No primary endpoint was used, because various exploratory analyses were performed.
Percentage of Participants With Adverse Events

Time frame: 24 weeks

No primary endpoint was used, because various exploratory analyses were performed.
Percentage of Participants With Adverse Drug Reactions

Time frame: 24 weeks

No primary endpoint was used, because various exploratory analyses were performed.
The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients

Time frame: 24 weeks

No primary endpoint was used, because various exploratory analyses were performed.
Percentage of Participants With Abnormal Changes in Sensory Examinations

Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Dec 25, 2006
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed