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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00330681
First received: May 26, 2006
Last updated: April 10, 2017
Last verified: April 2017
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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 ]
    ALSFRS-R Score: 0=worst; 48=best


Secondary Outcome Measures:
  • Death or a Specified State of Disease Progression [ Time Frame: 24 weeks ]
    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 ]
  • Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
    The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102

  • Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks [ Time Frame: baseline and 24 weeks ]
    The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40

  • Percentage of Participants With Adverse Events [ Time Frame: 24 weeks ]
  • Percentage of Participants With Adverse Drug Reactions [ Time Frame: 24 weeks ]
  • Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group [ Time Frame: 24 weeks ]
  • Percentage of Participants With Abnormal Changes in Sensory Examinations [ Time Frame: 24 weeks ]

Enrollment: 206
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
Experimental: 1
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).
Other Names:
  • Edaravone
  • Radicut
Placebo Comparator: 2
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00330681

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Chair: Koji Abe, professor Graduate School of Medicine and Dentistry, Okayama University
  More Information

Publications:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00330681     History of Changes
Other Study ID Numbers: MCI186-16
Study First Received: May 26, 2006
Results First Received: October 28, 2016
Last Updated: April 10, 2017

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Amyotrophic lateral sclerosis
free radical scavenger

Additional relevant MeSH terms:
Sclerosis
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
Phenylmethylpyrazolone
Antipyrine
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 23, 2017