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    HP:0003560: Muscular dystrophy

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (4)


    Name (Synonyms) Correlation
    drug137 ASP0367 Wiki 0.71
    drug1094 Covid-19 + patients Wiki 0.71
    drug1223 Difficulties lived by disabled children's parents in the period of COVID-19 pandemic Wiki 0.71
    Name (Synonyms) Correlation
    drug2916 Placebo Wiki 0.03

    Correlated MeSH Terms (3)


    Name (Synonyms) Correlation
    D009136 Muscular Dystrophies NIH 1.00
    D020388 Muscular Dystrophy, Duchenne NIH 0.71
    D002547 Cerebral Palsy NIH 0.41

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0001264 Spastic diplegia HPO 0.41

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 clinical trials


    1 A Randomized, Double Blind, Placebo-Controlled Phase 1b Study With Open-Label Extension to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Patients With Duchenne Muscular Dystrophy (DMD)

    The primary purpose of this study is to evaluate the safety and tolerability of ASP0367. This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle function of ASP0367.

    NCT04184882
    Conditions
    1. Duchenne Muscular Dystrophy (DMD)
    Interventions
    1. Drug: ASP0367
    2. Drug: Placebo
    MeSH:Muscular Dystrophies Muscular Dystrophy, Duchenne
    HPO:Muscular dystrophy

    Primary Outcomes

    Description: An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE observed after starting administration of the investigational product (IP) to 14 days after the last dose of IP for the double blind part or moving to the open-label extension part, whichever comes first. An IP-related TEAE is defined as any TEAE with a causal relationship of "yes" by the investigator.

    Measure: Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant vital sign values.

    Measure: Number of participants with vital sign abnormalities and/or AEs

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant body weight.

    Measure: Number of participants with body weight change abnormalities and/or AEs

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant 12-ECG values.

    Measure: Number of participants with electrocardiogram (ECG) abnormalities

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant echocardiography values.

    Measure: Number of participants with echocardiography abnormalities and/or AEs

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant laboratory values.

    Measure: Number of participants with laboratory value abnormalities and/or AEs

    Time: Up to Week 28

    Description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 6 items for suicidal behavior (1. Actual attempt, 2. Interrupted attempt, 3. Aborted attempt, 4. Preparatory acts or behavior, 5. Suicidal Behavior 6. Completed suicide,) will be reported.

    Measure: Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time: Baseline and up to Week 28

    Description: The Digit span test is a subtest of Wechsler Intelligence Scale for children (WISC). This test comprises 3 parts on the fifth edition (WISC-V). Digit Span Forward requires the subject to repeat numbers in the same order as presented by the interviewer. Digit Span Backward requires the subject to repeat the numbers in the reverse order of that presented by the interviewer. Digit Span Sequencing requires the subject to sequentially order the numbers presented by the interviewer. Scores of this test are based on each raw score and total raw score.

    Measure: Change from baseline in digit span test

    Time: Baseline and up to Week 24

    Secondary Outcomes

    Description: AUCtau will be recorded from the PK plasma samples collected.

    Measure: Pharmacokinetics (PK) of ASP0367 in plasma: AUC from the time of dosing to the start of next dosing interval (AUCtau)

    Time: Up to Week 2

    Description: Cmax will be recorded from the PK plasma samples collected.

    Measure: PK of ASP0367 in plasma: maximum concentration (Cmax)

    Time: Up to Week 2

    Description: Whole blood cell samples will be collected to measure percent change in target gene expressions.

    Measure: Pharmacodynamics (PD) of ASP0367: Percent change from baseline in peroxisome proliferator-activated receptor (PPAR) delta target genes expression levels in blood

    Time: Baseline and up to Week 4

    Description: Serum samples will be collected to record myostatin/follistatin ratio.

    Measure: PD of ASP0367: Percent change from baseline in serum myostatin/follistatin ratio

    Time: Baseline and up to Week 12

    Description: The PUL Assessment v2.0 includes a total of 23 upper limb test items, with the first entry item A used to define the starting functional level. The remaining 22 items are subdivided into 3 major dimension levels as following; shoulder level (6 items, maximum score of 12), elbow level (9 items, maximum score of 17) and distal level dimension (7 items, maximum score of 13). Positive change in scores indicates an improvement.

    Measure: Change from baseline in Performance of Upper Limb Module (PUL) (v2.0) assessment score

    Time: Baseline and up to Week 12

    Description: PedsQL Multidimensional Fatigue Scale comprises the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items) and Cognitive Fatigue Scale (6 items). A 5-point response scale in each item is utilized (0 never a problem; 1 almost never a problem; 2 sometimes a problem; 3 often a problem; 4 almost always a problem). Negative change in scores indicates an improvement. This scale is based on the subject's age and will be assessed by both subject and parent or legal guardian.

    Measure: Change from baseline on Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale

    Time: Baseline and up to Week 12

    Description: The 2-minute walk test (2MWT) is a measurement of endurance that assesses walking distance over 2 minutes. Only ambulatory subjects conduct the 2MWT in this study.

    Measure: Change from baseline in distance walked in 2 minutes assessed in meters

    Time: Baseline and up to Week 12

    Description: The a6MCT has been developed as a submaximal endurance test for both legs (leg-cycling) and arms (arm-cranking) for children who are expected to lose their walking ability in the near future or are wheel chair dependent. Only arm-cranking will be applied to this study.

    Measure: Percent change from baseline in the assisted 6 minute cycling test (a6MCT) maximal attained revolutions

    Time: Baseline and up to Week 12

    Description: The a6MCT has been developed as a submaximal endurance test for both legs (leg-cycling) and arms (arm-cranking) for children who are expected to lose their walking ability in the near future or are wheel chair dependent. Only arm-cranking will be applied to this study.

    Measure: Change from baseline in the a6MCT maximal attained revolutions

    Time: Baseline and up to Week 12

    Description: The fat fraction by MRS will be assessed for the vastus lateralis (VL) and soleus (SOL) muscles.

    Measure: Change from baseline in fat fraction by magnetic resonance spectroscopy (MRS)

    Time: Baseline, Week 12 and Week 24
    2 COVID-19 Pandemic From the Perspective of Parents of Disabled Children

    Pandemic period could affect the disabled children's rehabilitation and follow-up negatively because of preventive measures and this could create adverse results on their parents. In this research, it is aimed to determine the positive and negative effects of pandemic on parents and disabled children and to provide an insight for future solutions.

    NCT04525742
    Conditions
    1. COVID-19
    2. Disabilities Multiple
    3. Cerebral Palsy
    4. Muscular Dystrophies
    Interventions
    1. Other: Difficulties lived by disabled children's parents in the period of COVID-19 pandemic
    MeSH:Muscular Dystrophies Cerebral Palsy
    HPO:Athetoid cerebral palsy Cerebral palsy Muscular dystrophy Spastic diplegia

    Primary Outcomes

    Description: Difficulties related to rehabilitation facilities, other medical conditions or ortosis could increase because of Covid 19 pandemic unique conditions

    Measure: A questionnaire that we created will be used to determine the difficulties experienced by disabled children's parents during Covid 19 pandemic related to their medical follow-up

    Time: 4 weeks

    Secondary Outcomes

    Description: The Fear of COVID-19 Scale, a seven-item scale, has robust psychometric properties. It is reliable and valid in assessing fear of COVID-19 among the general population and will also be useful in allaying COVID-19 fears among individuals. Score is minimum 7 pointts and maximum 35 points.

    Measure: The Fear of COVID-19 Scale

    Time: 4 weeks

    HPO Nodes


    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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