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Monoclonal Antibodies
Fremanezumab for Preventing Migraine in Children and Adolescents
Phase 3
Waitlist Available
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants rolling over from the phase 1 pediatric pharmacokinetic study (Study TV48125-CNS-10141) must weigh at least 17.0 kg on the day of study enrollment
Participants rolling over from the phase 1 pediatric pharmacokinetic study (Study TV48125-CNS-10141) must have a body mass index ranging from the 5th to 120% of the 95th percentile, inclusive, on the day of study enrollment
Must not have
Participants rolling over from the phase 1 pharmacokinetic study (TV48125-CNS-10141) must not have a current or past medical history of hemiplegic migraine
Participants rolling over from the pivotal efficacy studies (TV48125-CNS-30082 or TV48125-CNS-30083) must not have a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or be concomitantly using lamotrigine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 - day 393
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing an injectable medication called fremanezumab to prevent migraines in children and teenagers aged 6 to 17. The medication works by blocking signals in the brain that cause headaches. Fremanezumab has been investigated for the preventive treatment of migraine in adults.
Who is the study for?
This trial is for children and adolescents aged 6 to 17 who have migraines. They must have been part of previous related studies, be in good health, not pregnant or nursing, without significant medical history like hemiplegic migraine or severe allergies to proteins. Participants need to weigh at least 17 kg and meet certain vaccine requirements.
What is being tested?
The study tests the long-term safety and effectiveness of a medication called Fremanezumab when injected under the skin as a preventive treatment for migraines in young participants. The trial will last up to five years.
What are the potential side effects?
While specific side effects are not listed here, Fremanezumab may cause reactions at the injection site, flu-like symptoms, allergic reactions or other potential side effects which will be closely monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 17.0 kg and am moving from a previous study.
Select...
My BMI is between the 5th and 120% of the 95th percentile.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had a hemiplegic migraine.
Select...
I have no history of severe allergic reactions to proteins or specific skin conditions, and I'm not taking lamotrigine.
Select...
I don't have ongoing infections or a history of HIV, TB, Lyme disease, hepatitis B/C, or active COVID-19.
Select...
I have not had hemiplegic migraines and am coming from a specific study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 - day 393
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 - day 393
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of abnormal vital signs
Incidence of adverse events
Yes/No suicidality ideation
Secondary study objectives
Mean change in the PedMIDAS questionnaire score
Proportion of participants developing antidrug antibodies (ADAs) throughout the study
Side effects data
From 2022 Phase 4 trial • 353 Patients • NCT040412841%
COVID-19
1%
C-reactive protein increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-blind Phase: Placebo
Double-blind Phase: Fremanezumab
Open-label Phase: Placebo/Fremanezumab Dose 2
Open-label Phase: Fremanezumab Dose 1/Fremanezumab Dose 2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: FremanezumabExperimental Treatment1 Intervention
The dose of Fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fremanezumab
2016
Completed Phase 4
~5540
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Migraine treatments work through various mechanisms to alleviate symptoms and prevent attacks. CGRP inhibitors, like Fremanezumab, block the activity of the calcitonin gene-related peptide (CGRP), a molecule involved in migraine pathophysiology, thereby reducing inflammation and pain transmission.
Triptans, another common treatment, activate serotonin receptors (5-HT1B/1D) to constrict blood vessels and inhibit the release of pro-inflammatory neuropeptides. NSAIDs, such as diclofenac, reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2).
Understanding these mechanisms is crucial for migraine patients as it helps in selecting the most effective treatment tailored to their specific migraine triggers and symptoms, potentially improving their quality of life.
The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis.
The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis.
Find a Location
Who is running the clinical trial?
Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
256 Previous Clinical Trials
3,486,106 Total Patients Enrolled
8 Trials studying Migraine
5,319 Patients Enrolled for Migraine
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
97 Previous Clinical Trials
39,309 Total Patients Enrolled
7 Trials studying Migraine
5,319 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you were part of the earlier study, you cannot have any major health problems related to the heart, hormones, stomach, urinary system, blood, liver, immune system, nervous system, eyes, lungs, or kidneys, or any severe infections.I have never had a hemiplegic migraine.I haven't had a live vaccine in the last 12 weeks.If you were in another study before, you should not have had any serious mental health issues or thoughts of harming yourself in the past 2 years.I have no history of severe allergic reactions to proteins or specific skin conditions, and I'm not taking lamotrigine.I don't have HIV, TB, Lyme disease, hepatitis B or C, and I'm not currently infected with COVID-19.If you were part of the main studies, you should not have any important abnormal results on your baseline heart test, as decided by the doctor.I have received all vaccines recommended for my age as per local guidelines.I have not had allergic reactions to injected proteins, Stevens-Johnson Syndrome, toxic epidermal necrolysis, or used lamotrigine.If you were in the previous study (TV48125-CNS-10141), you should not have any important heart problems found in the baseline ECG.I don't have ongoing infections or a history of HIV, TB, Lyme disease, hepatitis B/C, or active COVID-19.I haven't had a live vaccine in the last 12 weeks.I weigh at least 17.0 kg and am enrolling from a previous study.I have received all vaccines recommended for my age.If you were in the previous study, you should not have a serious psychiatric condition, attempted suicide before, or had thoughts of ending your life with a plan in the past 2 years, as decided by the doctor.I weigh at least 17.0 kg and am moving from a previous study.I have not had hemiplegic migraines and am coming from a specific study.I was part of a previous study and am continuing the same medication.My BMI is between the 5th and 120% of the 95th percentile.
Research Study Groups:
This trial has the following groups:- Group 1: Fremanezumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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