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Monoclonal Antibodies

Fremanezumab for Preventing Chronic Migraine

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 experienced 8 migraines in the past month?

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1, and month 3

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effects of a new migraine prevention drug, fremanezumab, to a placebo. The study will last 48 months and will look at safety, effectiveness, and antibody response.

Who is the study for?

This trial is for young patients aged 6 to 17 who suffer from chronic migraines, experiencing at least 8 migraines and a total of 15 headaches per month. They should have been on stable migraine medication for two months and diagnosed with migraines over six months ago. Caregivers can apply for their children if they commit to daily headache tracking.

What is being tested?

The study tests the effectiveness of Fremanezumab against a placebo in preventing chronic migraines in young patients. Participants will be randomly assigned to receive either the actual drug or a placebo, and the trial will last up to four years.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with similar medications include injection site reactions, allergic reactions, fatigue, nausea, and potential long-term immunogenicity issues.

Eligibility Criteria

Inclusion Criteria

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

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I have experienced 8 migraines in the past month.

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The participant or parent/caregiver maintain a prospectively collected headache diary

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I am willing to keep a daily headache diary during the study.

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I have had 15 headaches in the past month.

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I was diagnosed with migraines over 6 months ago.

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I am applying for this trial as my child's 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 headache days of at least moderate severity 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 / 6Eligibility criteria met