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Inclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies |
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(TV48125-CNS-30082 or TV48125-CNS-30083) |
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Participants have completed the pivotal efficacy study and, in the opinion of the |
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Investigator or the Sponsor, are able to complete the study in a safe and compliant |
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way |
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Participants may continue with a stable dose/regimen of the preventive medication they |
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The participant weighs at least 17.0 kg on the day of study enrollment |
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were taking during the pivotal efficacy studies |
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The participant continues to meet appropriate criteria carried forward from the |
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pivotal efficacy study |
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The participant has received all recommended age-appropriate vaccines according to |
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local standard of care and schedule |
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NOTE: Additional criteria apply; please contact the investigator for more information |
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The participant weighs at least 17.0 kg on the day of study enrollment |
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Inclusion Criteria for Participants Rolling Over from the Phase 1 Pediatric Pharmacokinetic |
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Study (Study TV48125-CNS-10141) |
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The participant/caregiver has demonstrated compliance with the electronic headache |
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diary during the 28-day baseline period by entry of headache data on a minimum of 21 |
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out of 28 days (approximately 75% diary compliance) |
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The participant has received all recommended age-appropriate vaccines according to |
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local standard of care and schedule |
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Only |
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The participant has a body mass index ranging from the 5th to 120% of the 95th |
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percentile, inclusive, on the day of study enrollment |
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Not using preventive medications or using no more than 2 preventive medications for |
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migraine or other medical condition, as long as the dose and regimen have been stable |
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for at least 2 months prior to screening (visit 1) |
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NOTE: Additional criteria apply; please contact the investigator for more information |
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Inclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies |
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(TV48125-CNS-30082 and TV48125-CNS-30083) for Safety and antidrug antibody (ADA) Assessment |
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• Participants may be included in this study if they sign and date the informed consent |
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document or upon consent of a parent or guardian, if the participant is younger than the |
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age of consent, accompanied by assent of the participant |
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Exclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies
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(TV48125-CNS-30082 or TV48125-CNS-30083)
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In the judgment of the investigator, the participant has a clinically significant
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abnormal finding on study entry, including hematology, blood chemistry, coagulation
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tests, or urinalysis values/findings (abnormal tests may be repeated for
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confirmation)
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The participant has a current history of a clinically significant psychiatric
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condition, any prior history of a suicide attempt, or a history of suicidal ideation
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with a specific plan within the past 2 years, at the discretion of the investigator
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The participant has an ongoing infection or a known history of human immunodeficiency
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virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known
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active infection of coronavirus disease 2019 (COVID-19)
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The participant has a history of hypersensitivity reactions to injected proteins
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including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis
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syndrome, or the participant is concomitantly using lamotrigine
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The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and
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measles, mumps, and rubella vaccine) within the 12-week period prior to screening
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Note: If a medical need arises during the study, the participant may receive a live
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attenuated vaccine
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The participant is pregnant or nursing
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In the judgment of the investigator, the participant has an abnormal finding on the
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baseline 12-lead ECG considered clinically significant
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The patient has a current or past medical history of hemiplegic migraine
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NOTE: Additional criteria apply; please contact the investigator for more information
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Exclusion Criteria for Participants Rolling Over from the Phase 1 Pharmacokinetic Study
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(TV48125-CNS-10141)
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The participant has any clinically significant cardiovascular (including congenital
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cardiac anomalies or thromboembolic events), endocrine, gastrointestinal
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genitourinary, hematologic, hepatic, immunologic, neurologic, ophthalmic, pulmonary
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renal disease, or complications of an infection, at the discretion of the
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investigator
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The participant has a current history of a clinically significant psychiatric
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condition, any prior history of a suicide attempt, or a history of suicidal ideation
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with a specific plan within the past 2 years, at the discretion of the investigator
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The participant has an ongoing infection or a known history of human immunodeficiency
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virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known
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active infection of coronavirus disease 2019 (COVID-19)
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The participant has a history of hypersensitivity reactions to injected proteins
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including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis
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syndrome, or the participant is concomitantly using lamotrigine
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The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and
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measles, mumps, and rubella vaccine) within the 12-week period prior to screening
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Note: If a medical need arises during the study, the participant may receive a live
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attenuated vaccine
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The participant is pregnant or nursing
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In the judgment of the investigator, the participant has an abnormal finding on the
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baseline 12-lead ECG considered clinically significant
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The patient has a current or past medical history of hemiplegic migraine
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NOTE: Additional criteria apply; please contact the investigator for more information
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Exclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies
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(TV48125-CNS-30082 and TV48125-CNS-30083) for Safety and antidrug antibody (ADA) Assessment
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Only: Not Applicable
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