Fremanezumab for Preventing Migraine in Children and Adolescents

Recruiting at 72 trial locations

Overseen By Nayla Chaijale

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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

476 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug fremanezumab for preventing migraine in children and adolescents?

Fremanezumab has been shown to significantly reduce the frequency of migraines and the need for acute headache medication in adults, as demonstrated in multiple phase III studies. While specific data for children and adolescents is not provided, its effectiveness in adults suggests potential benefits for younger populations as well. ^{1 2 3 4 5}

Is fremanezumab safe for use in humans?

Fremanezumab has been shown to be generally safe in humans, with clinical trials indicating good tolerability and no significant difference in treatment-related adverse reactions compared to placebo. The most common mild side effect is an injection site reaction, such as redness or swelling. ^{1 2 6 7 8}

How is the drug fremanezumab different from other migraine treatments?

Fremanezumab is unique because it is a monoclonal antibody that specifically targets the calcitonin gene-related peptide (CGRP), which plays a key role in migraine development. It is administered as a subcutaneous injection, offering flexible dosing options of either once a month or quarterly, and has shown significant efficacy in reducing migraine frequency with a favorable safety profile. ^{1 2 4 6 8}

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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, 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

Findings from Research

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Fremanezumab: First Global Approval. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Fremanezumab: a disease-specific option for the preventive treatment of migraine, including difficult-to-treat migraine. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials. [2020]

7. United States 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. [2020]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Review of Tolerability of Fremanezumab for Episodic and Chronic Migraine. [2023]