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Completed

NCT Number: NCT01492686

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic criteria El Escorial and revised 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.

Treatment and study plan

MCI-186

Drug

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).

Placebo

Drug

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).

MCI-186 in open label phase

Drug

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

Primary outcomes

  1. 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

    0=worst; 48=best

Secondary outcomes

  1. Number of Participants With Death or a Specified State of Disease Progression

    Time frame: 24 weeks

    Any of "death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech" was defined as an event.

  2. Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

    Time frame: baseline and 24 weeks

  3. 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. 0=worst; 102=best

  4. 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, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best

  5. Percentage of Participants With Adverse Events

    Time frame: 24 weeks

  6. Percentage of Participants With Adverse Drug Reactions

    Time frame: 24 weeks

  7. Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)

    Time frame: 24 weeks

  8. Percentage of Participants With Abnormal Values in Sensory Examinations

    Time frame: baseline and 24 weeks

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2011
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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