What side effects are associated with this type of intervention?

Common treatments for migraines, particularly CGRP inhibitors like Fremanezumab, often include side effects such as injection site reactions (pain, redness, or swelling), constipation, and muscle cramps or spasms. Other treatments for migraines, such as triptans, can cause dizziness, fatigue, dry mouth, and, in rare cases, more serious cardiovascular issues. Non-invasive neuromodulation devices may cause mild adverse events like tingling, warmth, or numbness in the treated area. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including CGRP inhibitors similar to fremanezumab. Notable CGRP inhibitors include erenumab (Aimovig), galcanezumab (Emgality), and eptinezumab (Vyepti). These medications work by targeting the calcitonin gene-related peptide (CGRP) pathway, which plays a crucial role in migraine pathophysiology. Additionally, triptans such as sumatriptan and zolmitriptan have been widely used for acute migraine treatment. These drugs offer various administration routes, including oral, subcutaneous, and intranasal, providing flexibility in managing migraine attacks.

What other types of research exist?

Promising novel alternatives to Fremanezumab for migraine treatment in 2024 include other CGRP receptor antagonists such as Eptinezumab and Galcanezumab. Additionally, Lasmiditan, a serotonin (5-HT1F) receptor agonist, and new formulations of triptans like Zolmitriptan and Sumatriptan are also noteworthy options.

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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 below

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I weigh at least 17.0 kg and am moving from a previous study.

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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:

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I have never had a hemiplegic migraine.

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I have no history of severe allergic reactions to proteins or specific skin conditions, and I'm not taking lamotrigine.

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I don't have ongoing infections or a history of HIV, TB, Lyme disease, hepatitis B/C, or active COVID-19.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - day 393 for reporting.

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 • NCT04041284

COVID-19

C-reactive protein increased

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.