A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    550
  • sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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Updated on 10 October 2021
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body mass index
headache
preventive medication
migraine in children

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 60 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

Details
Condition Migraine, Primary Stabbing Headache, Migraine (Adult), Migraine and Cluster Headaches, Migraine (Pediatric), migraines
Treatment Fremanezumab
Clinical Study IdentifierNCT04530110
SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last Modified on10 October 2021

Eligibility

 Yes No Not Sure

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 the 95th percentile, inclusive, on the day of study enrollment
Not using preventive medications or using no more than 1 preventive medication 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, 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, nursing, or taking a combined estrogen and progestogen hormonal contraceptive
In the judgment of the investigator, the participant has an abnormal finding on the baseline 12-lead ECG considered clinically significant
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, nursing, or taking a combined estrogen and progestogen hormonal contraceptive
In the judgment of the investigator, the participant has an abnormal finding on the baseline 12-lead ECG considered clinically significant
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
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