Fremanezumab for Preventing Migraine in Children and Adolescents

No longer recruiting at 77 trial locations

Overseen By Nayla Chaijale

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Teva Branded Pharmaceutical Products R&D LLC

Must be taking: Preventive medications

Must not be taking: Lamotrigine

Disqualifiers: Psychiatric conditions, Infections, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 84 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests fremanezumab, a medication designed to prevent migraines in children and teens aged 6 to 17. The main goal is to assess the long-term safety and tolerability of this treatment. Researchers also aim to evaluate fremanezumab's effectiveness in reducing migraines and its potential to trigger immune reactions. Children currently participating in related studies or with stable migraine prevention routines may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential availability of a new migraine prevention treatment for children and teens.

Will I have to stop taking my current medications?

Participants can continue with a stable dose of preventive medication they were taking during the pivotal efficacy studies. If not using preventive medications, they can use up to 2 preventive medications as long as the dose has been stable for at least 2 months before screening.

Is there any evidence suggesting that fremanezumab is likely to be safe for children and adolescents?

Research has shown that fremanezumab is generally safe for children and teens with migraines. Studies have found that it can significantly reduce the number of migraine days without causing serious side effects. The SPACE study specifically examined how children and teens tolerated fremanezumab and found it to be well-tolerated.

Some common side effects were mild, such as reactions at the injection site. Fremanezumab is already approved by the FDA for preventing migraines in adults, suggesting its safety. However, this trial aims to confirm its long-term safety for younger age groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Fremanezumab is unique because it targets a specific protein called calcitonin gene-related peptide (CGRP), which plays a crucial role in triggering migraines. Unlike current treatments for migraines in children and adolescents, which often include medications like triptans or preventive drugs such as topiramate, fremanezumab offers a more targeted approach by directly inhibiting CGRP. Researchers are excited about fremanezumab because it not only offers a novel mechanism of action but also has the potential for convenient administration with dosing adjustments based on weight, every three months. This could make managing migraines more effective and easier for young patients and their caregivers.

What evidence suggests that fremanezumab might be an effective treatment for migraine in children and adolescents?

Research shows that fremanezumab, which participants in this trial will receive, helps reduce migraine days in children and teens. Studies have found that it significantly lowers the number of migraines and headaches each month compared to a placebo, meaning those taking fremanezumab experienced fewer migraines. The treatment is safe and well-tolerated by young people. Strong evidence supports its use in preventing migraines, helping kids and teens feel better and have fewer headaches. ^{1 2 4 6 7}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants rolling over from the pivotal efficacy studies (TV48125-CNS-30082 or TV48125-CNS-30083) must 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

I have received all vaccines recommended for my age as per local guidelines.

Participants rolling over from the phase 1 pediatric pharmacokinetic study (Study TV48125-CNS-10141) must have 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)

Exclusion Criteria

Participants rolling over from the phase 1 pharmacokinetic study (TV48125-CNS-10141) must not be pregnant or nursing

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous fremanezumab for the preventive treatment of migraine

84 months

Visits every 3 months for dose adjustment based on weight

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fremanezumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Fremanezumab Experimental Treatment 1 Intervention

The dose of Fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.

Fremanezumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as Ajovy for:

• Prevention of migraines in adults

Approved in European Union as Ajovy for:

• Prevention of migraines in adults

Approved in United Kingdom as Ajovy for:

• Prevention of migraines in adults

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D LLC

Lead Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Published Research Related to This Trial

Fremanezumab is a fully humanized monoclonal antibody that targets calcitonin gene-related peptide, which plays a key role in migraine pathophysiology, and has shown significant reductions in migraine frequency and related disability in phase III studies involving adults.

Approved by the US FDA in September 2018 for preventive migraine treatment, fremanezumab is also being explored for cluster headaches and post-traumatic headache disorder, although a study for chronic cluster headaches was suspended due to futility analysis results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fremanezumab: First Global Approval. Hoy, SM.[2019]

Fremanezumab, a monoclonal antibody targeting CGRP, significantly reduced the number of migraine days in patients with episodic and chronic migraines who were already on stable preventive medications, showing a reduction of 12.4 days compared to 7.4 days for placebo.

The treatment was found to be safe, with mostly mild and transient side effects, and no serious adverse events linked to the treatment, indicating it can be a reliable add-on therapy for migraine prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. Cohen, JM., Dodick, DW., Yang, R., et al.[2022]

Fremanezumab, a CGRP monoclonal antibody, has been shown to be effective in preventing both episodic and chronic migraines, with multiple clinical trials demonstrating its superiority over placebo.

The medication is well-tolerated, with treatment-related adverse reactions similar to those of placebo, primarily consisting of mild-to-moderate injection site reactions, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Tolerability of Fremanezumab for Episodic and Chronic Migraine. Root, S., Ahn, K., Kirsch, J., et al.[2023]

Ajovy (fremanezumab) is an effective monoclonal antibody for preventing migraines, showing positive results in Phase III clinical trials for both episodic and chronic migraine sufferers.

The treatment has a favorable safety profile, with no serious adverse events reported, making it a promising option for adults experiencing frequent migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fremanezumab autoinjector pen for the prevention of migraine. Weatherall, MW.[2022]

Fremanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, has been shown to be a generally safe and well-tolerated preventive treatment for chronic and episodic migraines in a pooled analysis of 2566 patients from four placebo-controlled studies.

The most common adverse events were mild to moderate injection site reactions, with serious adverse events being rare and not linked to the drug, indicating that fremanezumab has a favorable safety profile compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinical Trials. Silberstein, SD., McAllister, P., Ning, X., et al.[2020]

Citations

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ir.tevapharm.com

ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-Positive-Efficacy-and-Safety-Data-of-AJOVY-fremanezumab-for-the-Prevention-of-Episodic-Migraine-in-Children-and-Adolescents-from-Phase-3-SPACE-Trial/default.aspx

Teva Presents Positive Efficacy and Safety Data of AJOVY ...

AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period ...

2.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000211143

Efficacy and Safety of Fremanezumab for the Preventive ...

These findings demonstrate the efficacy, safety, and tolerability of fremanezumab in children and adolescents with EM.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04530110

NCT04530110 | A Study to Test if Fremanezumab is ...

The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40888173/

Fremanezumab for the treatment of migraine

There is class I evidence for the efficacy of fremanezumab in the prophylaxis of both EM and CM, by reducing 1 to 2 monthly migraine days over ...

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neurologylive.com

neurologylive.com/view/reaction-significance-fremanezumab-expanded-indication-pediatric-migraine-patricia-pozo-rosich

Reaction and Significance of Fremanezumab's Expanded ...

All told, the study was considered a success, with those on fremanezumab showing statistically significantly better change in monthly migraine ...

6.

ajovyhcp.com

ajovyhcp.com/moa/pediatric-patients/

Pediatric patients - AJOVY® (fremanezumab-vfrm) injection

Learn about AJOVY for the preventive treatment of episodic migraine in pediatric patients aged 6–17, weighing at least 45 kg. See safety info.

7.

clinicaladvisor.com

clinicaladvisor.com/news/ajovy-approved-for-pediatric-episodic-migraine-prevention/

Ajovy Approved for Pediatric Episodic Migraine Prevention

Findings showed that compared with placebo, treatment with fremanezumab led to a significantly greater reduction in monthly migraine days ( ...