The 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 84 months.
The study population will be composed of 3 subgroups of participants as follows: * Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) * Participants rolling over from the Phase 1 pediatric pharmacokinetic study (Study TV48125-CNS-10141) * Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) for safety follow-up and antidrug antibody (ADA) evaluation only
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
506
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly. Participants weighing \< threshold will receive Dose B subcutaneously monthly. Subcutaneously monthly, confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.
Teva Investigational Site 14319
Aurora, Colorado, United States
Teva Investigational Site 14368
Colorado Springs, Colorado, United States
Teva Investigational Site 14244
Jacksonville, Florida, United States
Teva Investigational Site 14325
Miami, Florida, United States
Teva Investigational Site 14250
West Palm Beach, Florida, United States
Incidence of adverse events
including local injection site reaction/pain
Time frame: Day 1 - Day 393
Incidence of participants with clinically significant changes in laboratory values
Time frame: Day 1 - Day 253
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Time frame: Day 1 - Day 253
Incidence of abnormal vital signs
(systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Time frame: Day 1 - Day 253
Incidence of abnormal physical examination findings
Time frame: Day 1- Day 393
Yes/No suicidality ideation
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.
Time frame: Day 1 - Day 393
Mean change in the number of headache days of at least moderate severity
Time frame: Day 1 - Day 253
Mean change in the number of migraine days
Time frame: Day 1 - Day 253
Proportion of participants reaching at least 50% reduction in the number of migraine days
Time frame: Day 1 - Day 253
Proportion of participants reaching at least 50% reduction in the number of headache days of at least moderate severity
Time frame: Day 1 - Day 253
Mean change in the number of days of use of any acute headache medications
Time frame: Day 1 - Day 253
Mean change in the PedMIDAS questionnaire score
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.
Time frame: Day 1 - Day 393
Proportion of participants developing antidrug antibodies (ADAs) throughout the study
The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Time frame: Day 1 - Day 393
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Teva Investigational Site 14255
West Palm Beach, Florida, United States
Teva Investigational Site 14243
Atlanta, Georgia, United States
Teva Investigational Site 14258
Savannah, Georgia, United States
Teva Investigational Site 14263
Hoffman Estates, Illinois, United States
Teva Investigational Site 14245
Wichita, Kansas, United States
...and 60 more locations