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Monoclonal Antibodies

Fremanezumab for Preventing Migraines

Verified Trial

Phase 3

Recruiting

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

Have you been using the same migraine medication for the past two months?

Have you experienced 8 migraines in the past month?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1, and month 3

Awards & highlights

Pivotal Trial

Summary

This trial is designed to see if the drug fremanezumab is effective in preventing migraines. It will last up to 36 months and will compare the drug to a placebo.

Who is the study for?

This trial is for children aged 6 to 17 who have been diagnosed with episodic migraines for over six months, experiencing at least 8 migraines and a total of 15 headaches in the past month. They should be on stable migraine medication for two months.

What is being tested?

The study tests if Fremanezumab is more effective than a placebo in preventing episodic migraines in young patients. It's designed to compare outcomes between the drug and placebo over up to three years, also assessing safety and immune response.

What are the potential side effects?

While not specified here, common side effects of Fremanezumab may include injection site reactions (pain or redness), itching, rash, muscle pain, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have been taking the same medication for your migraines for the past two months.

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I have experienced 8 migraines in the past month.

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I was diagnosed with migraines over 6 months ago.

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I have had 15 headaches in the past month.

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I am applying for my child as their caregiver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1, and month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1, and month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in the monthly average number of migraine days after the first dose of study drug

Secondary study objectives

Incidence of abnormal physical examination findings

Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings

Incidence of abnormal vital signs

+9 more

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FremanezumabExperimental Treatment1 Intervention

Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fremanezumab

2016

Completed Phase 4

~5540

0 / 5Eligibility criteria met