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Page last updated: 2024-10-30

edaravone and Respiration Disorders

edaravone has been researched along with Respiration Disorders in 3 studies

Respiration Disorders: Diseases of the respiratory system in general or unspecified or for a specific respiratory disease not available.

Research Excerpts

ExcerptRelevanceReference
" Endpoints included treatment-emergent adverse events (TEAEs), including AEs leading to discontinuation, serious adverse events (SAEs), and deaths."6.84A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies. ( Ishizaki, K; Kalin, A; Kim, A; Medina-Paraiso, E; Saita, T; Wasaki, M; Zhang, Y, 2017)
" Endpoints included treatment-emergent adverse events (TEAEs), including AEs leading to discontinuation, serious adverse events (SAEs), and deaths."2.84A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies. ( Ishizaki, K; Kalin, A; Kim, A; Medina-Paraiso, E; Saita, T; Wasaki, M; Zhang, Y, 2017)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's3 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Kalin, A1
Medina-Paraiso, E1
Ishizaki, K1
Kim, A1
Zhang, Y1
Saita, T1
Wasaki, M1
Abraham, A1
Nefussy, B1
Fainmesser, Y1
Ebrahimi, Y1
Karni, A1
Drory, VE1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2[NCT01492686]Phase 3137 participants (Actual)Interventional2011-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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

(NCT01492686)
Timeframe: baseline and 24 weeks

Interventionpercentage of FVC (Least Squares Mean)
MCI-186-15.61
Placebo of MCI-186-20.4

Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 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 (NCT01492686)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-18617.25
Placebo of MCI-18626.04

Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks

The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best (NCT01492686)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-186-15.91
Placebo of MCI-186-20.8

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

0=worst; 48=best (NCT01492686)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-186-5.01
Placebo of MCI-186-7.5

Percentage of Participants With Adverse Drug Reactions

(NCT01492686)
Timeframe: 24 weeks

Interventionpercentage of Participants (Number)
MCI-1862.9
Placebo of MCI-1867.4

Percentage of Participants With Adverse Events

(NCT01492686)
Timeframe: 24 weeks

Interventionpercentage of Participants (Number)
MCI-18684.1
Placebo of MCI-18683.8

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

(NCT01492686)
Timeframe: 24 weeks

,
Interventionpercentage of Participants (Number)
Blood bilirubin increasedBlood creatine phosphokinase increasedLiver function test abnormalWhite blood cell count decreased
MCI-186001.41.4
Placebo of MCI-1861.51.51.50

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

"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." (NCT01492686)
Timeframe: 24 weeks

,
InterventionCount of Participants (Number)
DeathDisability of independent ambulationLoss of upper limbs functionTracheotomyUse of respiratorUse of tube feedingLoss of useful speech
MCI-1860001001
Placebo of MCI-1860200013

Percentage of Participants With Abnormal Values in Sensory Examinations

(NCT01492686)
Timeframe: baseline and 24 weeks

,
Interventionpercentage of Participants (Number)
Numbness (at baseline)Numbness (at 24 week)Staggering (at baseline)Staggering (at 24 week)
MCI-1862.97.21.42.9
Placebo of MCI-1867.49.48.83.1

Trials

2 trials available for edaravone and Respiration Disorders

ArticleYear
A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017

Other Studies

1 other study available for edaravone and Respiration Disorders

ArticleYear
Early post-marketing experience with edaravone in an unselected group of patients with ALS.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2019, Volume: 20, Issue:3-4

    Topics: Aged; Amyotrophic Lateral Sclerosis; Cohort Studies; Disease Progression; Edaravone; Female; Humans;

2019