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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00424463
First received: January 17, 2007
Last updated: February 27, 2013
Last verified: February 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


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 ]

Enrollment: 181
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424463

Locations
Japan
National Hospital Organization Miyagi National Hospital
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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00424463     History of Changes
Other Study ID Numbers: MCI186-17
Study First Received: January 17, 2007
Last Updated: February 27, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Phenylmethylpyrazolone
Antioxidants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 22, 2014