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
Overview
- Phase
- Phase 3
- Intervention
- Fremanezumab
- Conditions
- Migraine
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Enrollment
- 506
- Locations
- 92
- Primary Endpoint
- Incidence of abnormal physical examination findings
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies (TV48125-CNS-30082 or TV48125-CNS-30083):
- •Participants have completed the pivotal efficacy study and, in the opinion of the Investigator or the Sponsor, are able to complete the study in a safe and compliant way.
- •Participants may continue with a stable dose/regimen of the preventive medication they were taking during the pivotal efficacy studies.
- •The participant continues to meet appropriate criteria carried forward from the pivotal efficacy study/
- •The participant has received all recommended age-appropriate vaccines according to local standard of care and schedule.
- •The participant weighs at least 17.0 kg on the day of study enrollment.
- •NOTE: Additional criteria apply; please contact the investigator for more information.
- •Inclusion Criteria for Participants Rolling Over from the Phase 1 Pediatric Pharmacokinetic Study (Study TV48125-CNS-10141):
- •The participant/caregiver has demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 out of 28 days (approximately 75% diary compliance).
- •The participant has received all recommended age-appropriate vaccines according to local standard of care and schedule.
Exclusion Criteria
- •Exclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies (TV48125-CNS-30082 or TV48125-CNS-30083):
- •In the judgment of the investigator, the participant has a clinically significant abnormal finding on study entry, including hematology, blood chemistry, coagulation tests, or urinalysis values/findings (abnormal tests may be repeated for confirmation).
- •The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, must be excluded.
- •The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).
- •The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
- •The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.
- •The participant is pregnant or nursing.
- •In the judgment of the investigator, the participant has an abnormal finding on the baseline 12-lead ECG considered clinically significant.
- •The participant has a current or past medical history of hemiplegic migraine.
- •NOTE: Additional criteria apply; please contact the investigator for more information.
Arms & Interventions
Fremanezumab
The dose of Fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.
Intervention: Fremanezumab
Outcomes
Primary Outcomes
Incidence of abnormal physical examination findings
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 vital signs
Time Frame: Day 1 - Day 253
(systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Incidence of adverse events
Time Frame: Day 1 - Day 393
including local injection site reaction/pain
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Time Frame: Day 1 - Day 253
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.
Secondary Outcomes
- Proportion of participants developing antidrug antibodies (ADAs) throughout the study(Day 1 - Day 393)
- Mean change in the number of headache days of at least moderate severity(Day 1 - Day 253)
- Proportion of participants reaching at least 50% reduction in the number of migraine days(Day 1 - Day 253)
- Proportion of participants reaching at least 50% reduction in the number of headache days of at least moderate severity(Day 1 - Day 253)
- Mean change in the number of days of use of any acute headache medications(Day 1 - Day 253)
- Mean change in the number of migraine days(Day 1 - Day 253)
- Mean change in the PedMIDAS questionnaire score(Day 1 - Day 393)