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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug111 | ASP0367 Wiki | 1.00 |
| drug2505 | Placebo Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020388 | Muscular Dystrophy, Duchenne NIH | 1.00 |
| D009136 | Muscular Dystrophies NIH | 0.71 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
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.
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 28Description: 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 28Description: 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 28Description: Number of participants with potentially clinically significant 12-ECG values.
Measure: Number of participants with electrocardiogram (ECG) abnormalities Time: Up to Week 28Description: Number of participants with potentially clinically significant echocardiography values.
Measure: Number of participants with echocardiography abnormalities and/or AEs Time: Up to Week 28Description: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or AEs Time: Up to Week 28Description: 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 28Description: 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 24Description: 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 2Description: Cmax will be recorded from the PK plasma samples collected.
Measure: PK of ASP0367 in plasma: maximum concentration (Cmax) Time: Up to Week 2Description: 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 4Description: 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 12Description: 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 12Description: 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 12Description: 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 12Description: 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 12Description: 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 12Description: 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 24Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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.
Drug Reports MeSH Reports HPO Reports