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There are 3 clinical trials
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab. The total duration of the study is planned to be up to 36 months.
Description: The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Measure: Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug Time: Baseline and Month 3Description: Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows: 0=never a problem; almost never a problem; sometimes a problem; often a problem; almost always a problem.
Measure: Mean change PedsQL after administration of the first dose of study drug Time: Baseline - Month 3Description: including local injection site reaction/pain
Measure: Number of adverse events Time: Baseline - Month 3Description: (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Measure: Incidence of abnormal vital signs Time: Baseline - Month 3Description: Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Measure: Yes/No suicidality ideation Time: Screening - Month 3Description: The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Measure: Number of participants developing antidrug antibodies (ADAs) throughout the study Time: Baseline - Month 3The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab The total duration of the study is planned to be 48 months.
Description: The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Measure: Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug Time: Baseline and Month 3Description: Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows: 0=never a problem; almost never a problem; sometimes a problem; often a problem; almost always a problem.
Measure: Mean change PedsQL after administration of the first dose of study drug Time: Baseline - Month 3Description: including local injection site reaction/pain
Measure: Number of adverse events Time: Baseline - Month 3Description: (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Measure: Incidence of abnormal vital signs Time: Baseline - Month 3Description: Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Measure: Yes/No suicidality ideation Time: Screening - Month 3Description: The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Measure: Number of participants developing antidrug antibodies (ADAs) throughout the study Time: Baseline - Month 3The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study). Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab. The total duration of the study is planned to be up to 60 months.
Description: including local injection site reaction/pain
Measure: Incidence of adverse events Time: Day 1 - Day 393Description: (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Measure: Incidence of abnormal vital signs Time: Day 1 - Day 253Description: Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Measure: Yes/No suicidality ideation Time: Day 1 - Day 393Description: The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Measure: Mean change in the PedMIDAS questionnaire score Time: Day 1 - Day 393Description: The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Measure: Proportion of participants developing antidrug antibodies (ADAs) throughout the study Time: Day 1 - Day 393Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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