Overview
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.
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
Eligibility
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.
- The participant weighs at least 17.0 kg on the day of study enrollment.
- The participant has a body mass index ranging from the 5th to 120% of the 95th
percentile, inclusive, on the day of study enrollment.
- Not using preventive medications or using no more than 2 preventive medications for
migraine or other medical condition, as long as the dose and regimen have been stable
for at least 2 months prior to screening (visit 1).
NOTE: Additional criteria apply; please contact the investigator for more information.
Inclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies
(TV48125-CNS-30082 and TV48125-CNS-30083) for Safety and antidrug antibody (ADA) Assessment
Only:
• Participants may be included in this study if they sign and date the informed consent
document or upon consent of a parent or guardian, if the participant is younger than the
age of consent, accompanied by assent of the participant.
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.
Exclusion Criteria for Participants Rolling Over from the Phase 1 Pharmacokinetic Study
(TV48125-CNS-10141):
- The participant has any clinically significant cardiovascular (including congenital
cardiac anomalies or thromboembolic events), endocrine, gastrointestinal,
genitourinary, hematologic, hepatic, immunologic, neurologic, ophthalmic, pulmonary,
renal disease, or complications of an infection, at the discretion of the
investigator.
- The participant has a current history of a clinically significant psychiatric
condition, any prior history of a suicide attempt, or a history of suicidal ideation
with a specific plan within the past 2 years, at the discretion of the investigator.
- 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.
Exclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies
(TV48125-CNS-30082 and TV48125-CNS-30083) for Safety and antidrug antibody (ADA) Assessment
Only: Not Applicable