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NCT Number: NCT00424463

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

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.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Hospital Organization Miyagi National Hospital

Watari-gun, Miyagi, Japan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

MCI-186

Drug

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 of MCI-186

Drug

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.

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 (seventh cycle) and at 24 week (twelfth cycle)

    0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.

Secondary outcomes

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

    Time frame: 24 weeks (from seventh cycle to twelfth cycle)

    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.

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

    Time frame: baseline (seventh cycle) and at 24 week (twelfth cycle)

    To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.

  3. Percentage of Participants With Adverse Events

    Time frame: 36 weeks (from seventh cycle to fifteenth cycle)

  4. Percentage of Participants With Adverse Drug Reactions

    Time frame: 36 weeks (from seventh cycle to fifteenth cycle)

  5. Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group

    Time frame: 36 weeks (from seventh cycle to fifteenth cycle)

  6. Percentage of Participants With Abnormal Changes in Sensory Examinations

    Time frame: 36 weeks (from seventh cycle to fifteenth cycle)

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 19, 2007
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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