A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT04530110|
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2020
Last Update Posted : November 17, 2020
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 60 months.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Fremanezumab||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age|
|Actual Study Start Date :||September 16, 2020|
|Estimated Primary Completion Date :||May 16, 2023|
|Estimated Study Completion Date :||May 24, 2024|
The dose of Fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.
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.
- Incidence of adverse events [ Time Frame: Day 1 - Day 393 ]including local injection site reaction/pain
- 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 [ Time Frame: Day 1 - Day 253 ](systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
- Incidence of abnormal physical examination findings [ Time Frame: Day 1- Day 393 ]
- Yes/No suicidality ideation [ Time Frame: Day 1 - Day 393 ]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.
- 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 [ Time Frame: Day 1 - Day 393 ]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.
- Proportion of participants developing antidrug antibodies (ADAs) throughout the study [ Time Frame: Day 1 - Day 393 ]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): NCT04530110
|United States, Florida|
|Teva Investigational Site 14244|
|Jacksonville, Florida, United States, 32256|
|Teva Investigational Site 14250|
|West Palm Beach, Florida, United States, 33407|
|Teva Investigational Site 14255|
|West Palm Beach, Florida, United States, 33409|
|United States, Georgia|
|Teva Investigational Site 14243|
|Atlanta, Georgia, United States, 30328|
|Teva Investigational Site 14258|
|Savannah, Georgia, United States, 31406|
|United States, Minnesota|
|Teva Investigational Site 14270|
|Minneapolis, Minnesota, United States, 55402|
|United States, Missouri|
|Teva Investigational Site 14256|
|Bridgeton, Missouri, United States, 63044-2513|
|United States, North Carolina|
|Teva Investigational Site 14248|
|Raleigh, North Carolina, United States, 27607|
|United States, Oklahoma|
|Teva Investigational Site 14363|
|Tulsa, Oklahoma, United States, 74136|
|United States, Texas|
|Teva Investigational Site 14273|
|Austin, Texas, United States, 78759|
|United States, Utah|
|Teva Investigational Site 14375|
|Salt Lake City, Utah, United States, 84109|
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|