CompletedPhase 3

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

United States, Canada, Finland499 participantsStarted 2020-09-16

Plain-language 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.

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: Day 1 up to Day 393

Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results

Timeframe: Day 1 up to Day 253

Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)

Timeframe: Baseline to last assessment (up to Day 253)

Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)

Timeframe: Baseline to last assessment (up to Day 253)

Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Timeframe: Day 1 up to Day 253

Number of Participants With Shift From Baseline to Last Assessment in Physical Examination Findings

Timeframe: Baseline to last assessment (up to Day 393)

Trial details

NCT IDNCT04530110

SponsorTeva Branded Pharmaceutical Products R&D LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-15

Results submitted2026-05-14

View on ClinicalTrials.gov More Migraine trials

Plain-language summary

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: Day 1 up to Day 393

Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results

Timeframe: Day 1 up to Day 253

Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)

Timeframe: Baseline to last assessment (up to Day 253)

Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)

Timeframe: Baseline to last assessment (up to Day 253)

Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Timeframe: Day 1 up to Day 253

Number of Participants With Shift From Baseline to Last Assessment in Physical Examination Findings

Timeframe: Baseline to last assessment (up to Day 393)