We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00424463
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: MCI-186 Drug: Placebo of MCI-186 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : January 2007
Primary Completion Date : May 2009
Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: 1 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.
Other Names:
  • Edaravone
  • Radicut
Placebo Comparator: 2 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.

Primary Outcome Measures :
  1. Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Adverse events, adverse drug reactions, laboratory test and sensory examinations. [ Time Frame: 36 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424463

National Hospital Organization Miyagi National Hospital
Watari-gun, Miyagi-ken, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Study Chair: Koji Abe, professor Graduate School of Medicine and Dentistry, Okayama University

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00424463     History of Changes
Other Study ID Numbers: MCI186-17
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Amyotrophic lateral sclerosis (ALS)

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents