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A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
EU CTIS ID: 2024-512837-34-00
What this study is testing
To evaluate the long-term safety and tolerability of subcutaneous test IMP in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal trial)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants Rolling Over from the Pivotal Efficacy Trials may be included only if they meet all of the following criteria: Completion of the pivotal efficacy trial and in the opinion of the Investigator/Sponsor able to complete the trial in a safe and compliant way
- Weight of at least 17.0 kg on the day of trial enrollment
- BMI ranging from the 5th to 120% of the 95th percentile, incl. at day1, based on the local standard Participants Rolling Over from Trial TV48125-CNS-10141: may be included only if they meet all of the following criteria
- Participants Rolling Over from Trial TV48125-CNS-10141: may be included only if they meet all of the following criteria; Participant is male/female, 6 - 17 years old (inclusive)
- Written informed consent is obtained from each participant's parent or legal guardian and written assent (according to local regulations) is obtained from each participant. Note: In some countries, participants aged 15 to 17 years (inclusive) may give written informed consent; however, the participant's parent(s) or legal guardian(s) must be informed, per local regulations. Note: In some countries, participants aged 15 to 17 years (inclusive) may give written informed consent; however, the participant's parent(s) or legal guardian(s) must be informed, per local regulations
- 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)
You likely can't join if
- Participants from the Pivotal Efficacy Trials (any criteria met): Significant abnormal finding on trial entry (e.g. hematology), repeat abnormal tests for confirmation
- Past or current history of cancer
- History of hypersensitivity reactions to injected proteins, incl. mAbs, history of Stevens-Johnson Syndrome, toxic epidermal necrolysis syndrome, or the participant in concomitantly using lamotrigine
- Current participation in another IMP/medical device trial
- Hepatic enzymes (ALT, AST, ALP) > 1.5× ULN after a repeat test confirmation, or suspected hepatocellular damage (fulfilling Hy's law)
- Serum creatinine > 1.5× the ULN, clinically significant proteinuria (urine dipstick +4), an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m2, as calculated by the revised Schwartz formula (eGFR=[0.413×Ht]/serum creatinine), or evidence of renal disease
See the full eligibility criteria
Who can join
- Participants Rolling Over from the Pivotal Efficacy Trials may be included only if they meet all of the following criteria: Completion of the pivotal efficacy trial and in the opinion of the Investigator/Sponsor able to complete the trial in a safe and compliant way
- Weight of at least 17.0 kg on the day of trial enrollment
- BMI ranging from the 5th to 120% of the 95th percentile, incl. at day1, based on the local standard Participants Rolling Over from Trial TV48125-CNS-10141: may be included only if they meet all of the following criteria
- Participants Rolling Over from Trial TV48125-CNS-10141: may be included only if they meet all of the following criteria; Participant is male/female, 6 - 17 years old (inclusive)
- Written informed consent is obtained from each participant's parent or legal guardian and written assent (according to local regulations) is obtained from each participant. Note: In some countries, participants aged 15 to 17 years (inclusive) may give written informed consent; however, the participant's parent(s) or legal guardian(s) must be informed, per local regulations. Note: In some countries, participants aged 15 to 17 years (inclusive) may give written informed consent; however, the participant's parent(s) or legal guardian(s) must be informed, per local regulations
- 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)
- Females who are postmenarchal or ≥12 years of age may be included only if they have a negative β-HCG test before day 1 or are sterile
- Females who are postmenarchal or ≥12 years of age and sexually active must use highly effective birth control methods with their male partners for the duration of the trial (ie, at least 2 months before day 1) and for 6 months after the last dose of the IMP. Males who are sexually active with female partners must use a condom for the duration of the trial and for 6 months after the last administration of the IMP
- The participant has received all recommended age-appropriate vaccines according to local standard of care and schedule
- The participant is in good health as determined by a medical and psychiatric history, medical examination, 12-lead ECG, serum chemistry, hematology, coagulation, urinalysis, and serology
- The participant/caregiver must be willing and able to comply with trial requirements and to remain at the clinic for the required duration during the trial period, and willing to return to the clinic for the followup evaluation as specified in this protocol
- Participant's parent(s) or legal guardian(s) must give written informed consent, and the participant must give assent (in accordance with local regulations) Note: In some countries, participants aged 15 to 17 years (inclusive) may give written informed consent; however, the participant's parent(s) or legal guardian(s) must be informed, per local regulations.
- Weight of at least 17.0 kg on the day of trial enrollment
- BMI ranging from the 5th to 120% of the 95th percentile, inclusive, at screening, based on the local standard.
- 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 day 1 Participants Rolling Over from the Pivotal Efficacy Trials: Remainder of criteria applies as per the trial protocol
- Participant may continue with a stable dose/regimen of the preventive medication they were taking during the pivotal efficacy trials
- Willing and able to comply with trial restrictions and to remain at the clinic for the required duration during the trial period and willing to return to the clinic for the follow-up evaluation as specified in this protocol
- Participant continues to meet appropriate criteria carried forward from the pivotal efficacy trial, as follows:
- Females who are postmenarchal or ≥12 years of age may be included only if they have a negative beta-human chorionic gonadotropin (β-HCG) test before day 1 or are sterile
- Females who are postmenarchal or ≥12 years of age and sexually active must use highly effective birth control methods with their male partners for the duration of the trial (ie, at least 2 months before day 1) and for 6 months after the last dose of IMP. Males who are sexually active with female partners must use a condom for the duration of the trial and for 6 months after the last administration of IMP
- Receipt of all recommended age-appropriate vaccines according to local standard of care and schedule
- Good health, determined by a medical and psychiatric history, medical examination, 12-lead ECG, serum chemistry, hematology, coagulation, urinalysis, and serology
What rules you out
- Participants from the Pivotal Efficacy Trials (any criteria met): Significant abnormal finding on trial entry (e.g. hematology), repeat abnormal tests for confirmation
- Past or current history of cancer
- History of hypersensitivity reactions to injected proteins, incl. mAbs, history of Stevens-Johnson Syndrome, toxic epidermal necrolysis syndrome, or the participant in concomitantly using lamotrigine
- Current participation in another IMP/medical device trial
- Hepatic enzymes (ALT, AST, ALP) > 1.5× ULN after a repeat test confirmation, or suspected hepatocellular damage (fulfilling Hy's law)
- Serum creatinine > 1.5× the ULN, clinically significant proteinuria (urine dipstick +4), an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m2, as calculated by the revised Schwartz formula (eGFR=[0.413×Ht]/serum creatinine), or evidence of renal disease
- Participant cannot fully participate in/successfully complete the trial for its full duration for any of the following reasons: -In custody due to an administrative or a legal decision or in residential treatment; -Participant/caregiver unable to be contacted in case of emergency; -Presence of any other condition, which makes the participant inappropriate for trial inclusion; -Participant is a relative of a trial center or sponsor employee who is directly involved in the trial
- Vulnerable participants (eg, people in detention) that are vulnerable due to other conditions than age
- Receipt of a live attenuated vaccine (eg, intranasal flu vaccine) within the 12-week period prior to day 1. Note: If a medical need arises during the trial, the participant may receive a live attenuated vaccine.
- The participant has a known hypersensitivity to the active substance or to any of the excipients of the trial drug.
- The participant has a current or past medical history of hemiplegic migraine.
- Pregnant or nursing
- Participants from Trial TV48125-CNS-10141 (any criteria met): Use of an intervention/device for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to day 1.
- Any clinically significant disease (e.g. cardiovascular)/complications of an infection
- Current history of clinically significant psychiatric condition/history of a suicide attempt/suicidal ideation with a specific plan within the past 2 years, at discretion of investigator
- Ongoing infection/known history of e.g. HIV infection/tuberculosis/Lyme disease/chronic hepatitis B or C, COVID-19
- Past or current history of cancer
- Pregnant or nursing
- History of hypersensitivity reactions to injected proteins, incl. mAbs/history of Stevens-Johnson Syndrome/toxic epidermal necrolysis syndrome, or participant is concomitantly using lamotrigine
- Participation in another trial of an IMP/medical device within 30 days/ 90 days for biologics or 5 half-lives previous to screening visit day (whichever is longer) or current participation in another trial of an IMP/medical device
- Exposure to a mAb targeting the calcitonin gene-related peptide pathway (erenumab, eptinezumab, galcanezumab, fremanezumab) during the 6 months prior to screening visit day
- Abnormal finding on day 1 12-lead ECG considered clinically significant
- Abnormal clinically significant finding on day 1 12-lead ECG
- Clinically significant abnormal finding on screening visit day, incl. hematology, blood chemistry, coagulation tests, urinalysis values/findings (repeat abnormal tests for confirmation)
- Hepatic enzymes (ALT, AST, ALP) > 1.5× the ULN on screening visit day after confirmation in a repeat test/suspected hepatocellular damage (fulfilling Hy's law)
- Serum creatinine > 1.5× the ULN, clinically significant proteinuria (urine dipstick +4), an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m2, as calculated by the revised Schwartz formula (eGFR=[0.413×Ht]/serum creatinine), or evidence of renal disease on the day of the screening visit. Remainder of criteria applies as per the trial protocol
- One of the following criteria is met:
- The participant is regularly using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
- Use of an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day 1
- Any clinically significant disease (e.g. cardiovascular), or complications of an infection
- History of clinically significant psychiatric condition/history of a suicide attempt/history of suicidal ideation with a specific plan within the past 2 years, at the discretion of the investigator
- Ongoing infection/known history of e.g. HIV infection/tuberculosis, Lyme disease, chronic hepatitis B or C, or a known infection of coronavirus disease 2019 (COVID-19)
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.