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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
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: treatment effectExperimental Treatment1 Intervention
No 2 arms and only 1 intervention
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,930,004 Total Patients Enrolled
3 Trials studying Migraine
92 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of feeling very scared in small, enclosed spaces.I have been diagnosed with migraine, following official guidelines.I am currently taking prescription pain medication for headaches or body pain.I agree not to change my preventive medications unless it's for migraines.I have had a stroke, TIA, or surgery on the arteries in my neck.I have a history of or suspect I have secondary headaches.I have used marijuana or CBD oil in the past year.I use medication to help me sleep every day.I am between 18 and 65 years old.Your recent ECG showed abnormal heart rhythms or patterns.I score 10 or higher on the Insomnia Severity Index.I have had a nerve block in my head or neck in the last 3 months.Your blood pressure is consistently very high, even after multiple measurements within a day.I have been diagnosed with obstructive sleep apnea or restless legs syndrome.I have been diagnosed with migraine, following specific guidelines.I have had botulinum toxin or anti-CGRP injections in the past 6 months.You have a body mass index (BMI) of 30 or higher.I am currently taking medication to prevent migraines.I do not have other major pain issues that could affect the study's results.I do not have severe heart problems like heart failure or a past heart attack.I regularly take painkillers or specific headache medicines more than half the month.I have 10-25 headache days a month, with at least 8 being long-lasting migraines.My migraines started when I was 50 or younger.
Research Study Groups:
This trial has the following groups:- Group 1: treatment effect
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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