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Monoclonal Antibodies

Fremanezumab for Migraine

Phase 4
Recruiting
Led By Sait Ashina, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria
Between the ages of 18 and 65 years
Must not have
Currently takes prescription opioids for headaches or body pain
Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will tell us if fremanezumab prevents migraine and improves sleep quality in people who suffer from migraines.

Who is the study for?
Adults aged 18-65 with migraines, experiencing 10-25 headache days a month, at least 8 being migraine days lasting over 4 hours if untreated. Must score ≥10 on the Insomnia Severity Index but not have severe sleep disorders like obstructive sleep apnea or restless legs syndrome. Cannot be using certain pain or sleep medications regularly, have serious heart/cerebrovascular conditions, history of substance abuse within last 5 years, or be pregnant/nursing without birth control.
What is being tested?
The trial is testing Fremanezumab's effect on preventing migraines and improving sleep quality in patients with frequent migraines. Participants will self-report daily assessments of migraine and sleep before treatment and for three months after starting treatment to see if there are changes in their condition.
What are the potential side effects?
While specific side effects for this trial aren't listed, common side effects of Fremanezumab may include injection site reactions (pain or redness), itching, rash, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with migraine, following official guidelines.
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I am between 18 and 65 years old.
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I have been diagnosed with migraine, following specific guidelines.
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I have 10-25 headache days a month, with at least 8 being long-lasting migraines.
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My migraines started when I was 50 or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking prescription pain medication for headaches or body pain.
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I have had a stroke, TIA, or surgery on the arteries in my neck.
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I have a history of or suspect I have secondary headaches.
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I have used marijuana or CBD oil in the past year.
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I use medication to help me sleep every day.
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I have been diagnosed with obstructive sleep apnea or restless legs syndrome.
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I am currently taking medication to prevent migraines.
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I do not have other major pain issues that could affect the study's results.
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I do not have severe heart problems like heart failure or a past heart attack.
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I regularly take painkillers or specific headache medicines more than half the month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fremanezumab and migraine
Fremanezumab and sleep

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatment effectExperimental Treatment1 Intervention
No 2 arms and only 1 intervention

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,861 Total Patients Enrolled
4 Trials studying Migraine
102 Patients Enrolled for Migraine
Teva Pharmaceuticals USAIndustry Sponsor
230 Previous Clinical Trials
188,108 Total Patients Enrolled
1 Trials studying Migraine
72 Patients Enrolled for Migraine
Sait Ashina, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

Media Library

Fremanezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04693533 — Phase 4
Migraine Research Study Groups: treatment effect
Migraine Clinical Trial 2023: Fremanezumab Highlights & Side Effects. Trial Name: NCT04693533 — Phase 4
Fremanezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04693533 — Phase 4
~24 spots leftby Nov 2025
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