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Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT01492686
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the 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. The study is also to examine the safety of MCI-186 to the ALS patients.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: MCI-186 Drug: Placebo Drug: MCI-186 in open label phase Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
Study Start Date : December 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Edaravone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 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). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Drug: MCI-186 in open label phase
All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.
Placebo Comparator: Arm 2 Drug: Placebo
Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Drug: MCI-186 in open label phase
All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.


Outcome Measures
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Primary Outcome Measures :
  1. Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Time to death from date of randomization [ Time Frame: 24 weeks ]
  2. Time to a certain state from date of randomization [ Time Frame: 24 weeks ]
    inability to walk alone; failure of arm function; tracheostomy; respirator installation; tubal feeding replenishment

  3. % Forced Vital Capacity (%FVC) [ Time Frame: 24 weeks ]
  4. Modified Norris scale score [ Time Frame: 24 weeks ]
  5. Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40 score) [ Time Frame: 24 weeks ]
  6. Adverse events, adverse drug reactions, laboratory test and sensory examinations [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients whose conditions are defined as "definite ALS"or "probable ALS"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 2 years after the onset of ALS.
  • Patients whose progress of the condition during 12 weeks before administration meet other requirements.

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.
  • 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
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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): NCT01492686


Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01492686     History of Changes
Other Study ID Numbers: MCI186-19
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Amyotrophic Lateral Sclerosis (ALS)

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