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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01492686

First Posted: December 15, 2011

Last Update Posted: October 12, 2017

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.

Information provided by (Responsible Party):

Mitsubishi Tanabe Pharma Corporation

Purpose

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	Intervention	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: MCI-186 Drug: Placebo Drug: MCI-186 in open label phase	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Edaravone

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

Time to death from date of randomization [ Time Frame: 24 weeks ]
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
% Forced Vital Capacity (%FVC) [ Time Frame: 24 weeks ]
Modified Norris scale score [ Time Frame: 24 weeks ]
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40 score) [ Time Frame: 24 weeks ]
Adverse events, adverse drug reactions, laboratory test and sensory examinations [ Time Frame: 24 weeks ]


Enrollment:	137
Study Start Date:	December 2011
Study Completion Date:	October 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
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

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


Responsible Party:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT01492686 History of Changes
Other Study ID Numbers:	MCI186-19
First Submitted:	December 11, 2011
First Posted:	December 15, 2011
Last Update Posted:	October 12, 2017
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

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