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

Purpose

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.

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:	An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 36 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, etc. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Adverse events, adverse drug reactions, laboratory test and sensory examinations. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	January 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
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: NCT00424463

Contacts


Contact: Clinical Trials Information Desk		cti-inq-ml@ml.mt-pharma.co.jp

Locations


Japan, Miyagi-ken
	National Hospital Organization Miyagi National Hospital	Recruiting
	Watari-gun, Miyagi-ken, Japan

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:	MCI186-17
First Received:	January 17, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00424463
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Amyotrophic lateral sclerosis (ALS)

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 October 03, 2008

Sponsored by:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00424463