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MCI-186

DRUG10 trials

Sponsors

Shionogi

Conditions

Acute Ischemic Stroke (AIS)Amyotrophic Lateral Sclerosis (ALS)HealthyHealthy Adult SubjectsHepatic ImpairmentRenal ImpairmentSevere Hepatic Impairment

Phase 1

Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
CompletedNCT03289234
ShionogiHealthy, Hepatic Impairment
Start: 2016-11-16End: 2018-07-24Updated: 2026-07-15
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
CompletedNCT03289208
ShionogiHealthy, Renal Impairment
Start: 2016-10-27End: 2018-04-20Updated: 2026-07-15
PK Study in Subjects With Severe Hepatic Impairment
CompletedNCT03664544
ShionogiHealthy, Severe Hepatic Impairment
Start: 2018-11-06End: 2019-03-25Updated: 2026-07-15
A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
CompletedNCT04029090
ShionogiHealthy Adult Subjects
Start: 2018-09-18End: 2018-10-23Updated: 2026-07-15
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
CompletedNCT04493281
ShionogiHealthy Adult Subjects
Start: 2019-03-22End: 2019-05-09Updated: 2026-07-15

Phase 2

Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
CompletedNCT00821821
ShionogiAcute Ischemic Stroke (AIS)
Start: 2009-02-28End: 2010-11-30Updated: 2026-07-16

Phase 3

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
CompletedNCT00330681
ShionogiAmyotrophic Lateral Sclerosis (ALS)
Start: 2006-05-31End: 2008-09-30Updated: 2026-07-21
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
CompletedNCT00415519
ShionogiAmyotrophic Lateral Sclerosis (ALS)
Start: 2006-12-31End: 2008-07-31Updated: 2026-07-21
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
CompletedNCT00424463
ShionogiAmyotrophic Lateral Sclerosis (ALS)
Start: 2007-01-31End: 2009-05-31Updated: 2026-07-21
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
CompletedNCT01492686
ShionogiAmyotrophic Lateral Sclerosis (ALS)
Start: 2011-12-31End: 2014-10-31Updated: 2026-07-21

Related Papers

The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis
Muscle & Nerve2023-07-318 citations
An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Variables of Edaravone in Subjects with Mild, Moderate, or No Renal Impairment.
2020-08-285 citations
Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning.
2020-08-146 citations
Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration2017-09-0539 citations
Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration2017-09-0532 citations
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
2017-05-15658 citations
A 24-Week, Phase III, Double-Blind, Parallel-Group Study of Edaravone (MCI-186) for Treatment of Amyotrophic Lateral Sclerosis (ALS) (P3.189)
Neurology2016-04-0515 citations
A Long-Term Safety and Efficacy Extension Study of Patients Diagnosed with Amyotrophic Lateral Sclerosis (ALS) and Treated with Edaravone (MCI-186) (P3.192)
Neurology2016-04-058 citations
A Double-Blind, Parallel-Group, Placebo-Controlled, 24-Week, Exploratory Study of Edaravone (MCI-186) for the Treatment of Advanced Amyotrophic Lateral Sclerosis (ALS) (P3.191)
Neurology2016-04-056 citations
Sustained Efficacy for up to 12 Months in an Active Extension of a Phase III Study of Edaravone (MCI-186) for Treatment of Amyotrophic Lateral Sclerosis (ALS) (P3.190)
Neurology2016-04-051 citations