A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
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|ClinicalTrials.gov Identifier: NCT04458857|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : June 11, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Fremanezumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age|
|Actual Study Start Date :||July 16, 2020|
|Estimated Primary Completion Date :||December 21, 2022|
|Estimated Study Completion Date :||December 21, 2022|
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.
Dose A or Dose B subcutaneous
Placebo Comparator: Placebo
- Mean change in the monthly average number of migraine days after the first dose of study drug [ Time Frame: Baseline - Month 3 ]
- Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug [ Time Frame: Baseline - Month 3 ]
- Number of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug [ Time Frame: Baseline - Month 3 ]
- Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug [ Time Frame: Baseline - Month 3 ]
- Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug [ Time Frame: Baseline and Month 3 ]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.
- Mean change PedsQL after administration of the first dose of study drug [ Time Frame: Baseline - Month 3 ]
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.
- Number of adverse events [ Time Frame: Baseline - Month 3 ]including local injection site reaction/pain
- Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings [ Time Frame: Baseline - Month 3 ]
- Incidence of abnormal vital signs [ Time Frame: Baseline - Month 3 ](systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
- Number of participants with clinically significant changes in laboratory values [ Time Frame: Baseline, Month 1, and Month 3 ]
- Incidence of abnormal physical examination findings [ Time Frame: Baseline - Month 3 ]
- Yes/No suicidality ideation [ Time Frame: Screening - Month 3 ]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.
- Number of participants developing antidrug antibodies (ADAs) throughout the study [ Time Frame: Baseline - Month 3 ]The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458857
|Contact: Teva U.S. Medical Information||1-888-483-8279||USMedInfo@tevapharm.com|
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|