Page last updated: 2024-10-28

idebenone and Respiration Disorders

idebenone 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
"Treatment with idebenone was safe and well tolerated with adverse event rates were similar in both groups."2.80Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. ( Bernert, G; Buyse, GM; Cuisset, JM; D'Angelo, MG; Finkel, RS; Goemans, N; McDonald, CM; Meier, T; Rummey, C; Schara, U; Straathof, CSM; Voit, T, 2015)

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's2 (66.67)24.3611
2020's1 (33.33)2.80

Authors

AuthorsStudies
Servais, L1
Straathof, CSM2
Schara, U2
Klein, A1
Leinonen, M1
Hasham, S1
Meier, T2
De Waele, L1
Gordish-Dressman, H1
McDonald, CM2
Mayer, OH1
Voit, T2
Mercuri, E2
Buyse, GM2
Muntoni, F1
D'Angelo, MG1
Bernert, G1
Cuisset, JM1
Finkel, RS1
Goemans, N1
Rummey, C1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids[NCT02814019]Phase 3255 participants (Actual)Interventional2016-09-30Terminated (stopped due to Interim analysis concluded to futility)
A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy[NCT01027884]Phase 365 participants (Actual)Interventional2009-07-31Completed
A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study[NCT03603288]Phase 3161 participants (Actual)Interventional2018-07-04Terminated (stopped due to Interim analysis concluded to futility of main study SIDEROS (SNT-III-012))
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52

Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 (NCT01027884)
Timeframe: Baseline and Week 52

Interventionpercentage of Predicted FVC (Mean)
Placebo-8.95
Idebenone-5.67

Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52

Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52 (NCT01027884)
Timeframe: Baseline and Week 52

Interventionpercentage (Geometric Mean)
Placebo-8.84
Idebenone-2.57

Change From Baseline to Week 52 in Quality of Life Assessed by PedsQLâ„¢ Paediatric Quality of Life Inventory

"PedsQL Quality of Life Inventory contains paediatric HRQOL measurements: Physical, Emotional,Social and School Functioning.~Item Scaling:~5-point Likert scale from 0 (Never) to 4 (Almost always). 3-point scale: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Young Child (ages 5-7).~Scores are transformed on a scale from 0 to 100 ( 0=100, 1=75, 2=50, 3=25, 4=0) Total Score: Sum of all the items over the number of items answered on all the Scales.~The values reported below are overall scores on Paediatric Quality of Life Inventory in Child/Teen Report. These scores were obtained by averaging scores for all the described subscales. The overall scores range between 0-100 with 0 = worst outcome and 100= best outcome" (NCT01027884)
Timeframe: Baseline and Week 52

Interventionunits on a scale (Mean)
Placebo2.46
Idebenone-1.34

Percentage of Patients Reporting Adverse Events

(NCT01027884)
Timeframe: 52 Weeks

Interventionpercentage of patients reporting AEs (Number)
Placebo94.1
Idebenone93.8

Change From Baseline to Week 52 in Muscle Strength

"The change from Baseline to Week 52 in muscle strength as measured by Hand-Held Myometry (HHM) was performed following standardized procedures. As almost all patients were non-ambulatory, only analyses of upper limb muscle strength were performed. Results for elbow flexors and for elbow extensors are reported below.The highest value of 3 consecutive measurements with an interval of at least 10 seconds were recorded.~The HHM was measured using MicroFET2, a digital hand held muscle tester. The selected unit of measure was Newtons (N)." (NCT01027884)
Timeframe: Baseline and Week 52

,
InterventionNewtons (Mean)
Elbow FlexorsElbow Extensors
Idebenone-2.320.26
Placebo0.131.32

Trials

2 trials available for idebenone and Respiration Disorders

ArticleYear
Long-term data with idebenone on respiratory function outcomes in patients with Duchenne muscular dystrophy.
    Neuromuscular disorders : NMD, 2020, Volume: 30, Issue:1

    Topics: Adolescent; Adult; Antioxidants; Child; Follow-Up Studies; Humans; Male; Muscular Dystrophy, Duchenn

2020
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015
Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Adolescent; Antioxidants; Child; Double-Blind Method; Humans; Male; Muscular Dystrophy, Duchenne; Pe

2015

Other Studies

1 other study available for idebenone and Respiration Disorders

ArticleYear
Efficacy of idebenone in Duchenne muscular dystrophy.
    Lancet (London, England), 2015, May-02, Volume: 385, Issue:9979

    Topics: Antioxidants; Humans; Male; Muscular Dystrophy, Duchenne; Respiration Disorders; Ubiquinone

2015