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

Sponsored by:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00330681

Purpose

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in 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.　And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: MCI-186 Drug: Placebo of MCI-186	Phase III

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner.

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Period until death or a certain state (i.e., inability to walk alone, failure of arm function, tracheostomy, respirator installation, tubal feeding replenishment), ％FVC, Modified Norris scale score, ALSAQ40 score, etc. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Adverse events, adverse drug reactions, laboratory test and sensory examinations [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	May 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MCI-186	Drug: MCI-186 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).
2: Placebo Comparator Placebo of MCI-186	Drug: Placebo of MCI-186 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).

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
Patients of less than 3 years after the onset of ALS.
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, severe heart disease, severe 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 participated in other trials 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330681

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Chair:

Koji Abe, professor

Graduate School of Medicine and Dentistry, Okayama University

More Information

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department I )
Study ID Numbers:	MCI186-16
Study First Received:	May 26, 2006
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00330681
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Amyotrophic lateral sclerosis
free radical scavenger

Study placed in the following topic categories:

Amyotrophic lateral sclerosis
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Lou Gehrig's disease

Sclerosis
Degenerative motor system disease
Neurodegenerative Diseases
Motor neuron disease
Motor Neuron Disease
Phenylmethylpyrazolone

Additional relevant MeSH terms:

Antioxidants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Free Radical Scavengers
Nervous System Diseases
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009