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Monoclonal Antibodies
Emgality for Migraine Prevention
Phase 4
Waitlist Available
Led By Rami Burstein
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
Experiences between 10 to 25 headaches days per month (during the last 3 months), with at least 8 of them being migraine days during which the migraines lasted more than 4 hours if untreated
Previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria
Must not have
Uncontrolled high blood pressure (systolic >160 mm Hg, diastolic >100 mm Hg) after 3 measurements within 24 hours
Received botulinum toxin or anti-CGRP-mAb injections within the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month before and 3 months after treatment
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is to study the mechanisms of action of CGRP targeted monoclonal antibodies in migraine prevention, specifically to see if they act inside or outside the brain and where.
Who is the study for?
This trial is for adults aged 18-65 with a history of migraines, experiencing 10-25 headache days per month. Participants must not be on migraine prevention therapy or have other significant pain issues, severe cardiac disease, substance abuse history, or use marijuana. Pregnant women and those not using birth control are excluded.
What is being tested?
The study tests the effects of Emgality (Galcanezumab), a CGRP-targeted monoclonal antibody for preventing migraines. It aims to determine whether its main effect is inside or outside the brain and identify specific action sites.
What are the potential side effects?
Potential side effects may include injection site reactions such as pain or irritation, allergic reactions to the drug's components, fatigue, constipation or diarrhea. Individual experiences with side effects can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 10-25 headache days a month, with at least 8 being long-lasting migraines.
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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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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...
My blood pressure is not higher than 160/100 mm Hg.
Select...
I have had botulinum toxin or anti-CGRP-mAb injections in the past 6 months.
Select...
I have used marijuana or CBD oil in the past year.
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I do not have severe heart problems like heart failure or a past heart attack.
Select...
I have had a nerve block in my head or neck in the last 3 months.
Select...
I have or might have headaches caused by another health condition.
Select...
I have had a stroke, TIA, or surgery on the arteries in my neck.
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I regularly take painkillers or specific headache medicines more than half the month.
Select...
I am currently taking prescription opioids for pain.
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I do not have other major pain issues that could affect the study's results.
Select...
I am currently taking medication to prevent migraines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month before and 3 months after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month before and 3 months after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Cortex
Change in abnormal brain functioning - food deprivation
Change in abnormal brain functioning - light sensitivity
+5 moreSide effects data
From 2023 Phase 4 trial • 701 Patients • NCT0408431435%
COVID-19
19%
Nasopharyngitis
15%
Constipation
9%
Fatigue
7%
Hypertension
6%
Depression
6%
Back pain
6%
Migraine
6%
Immunisation reaction
6%
Headache
5%
Nausea
5%
Arthralgia
4%
Alopecia
4%
Vertigo
4%
Pain in extremity
3%
Cough
3%
Pyrexia
3%
Cystitis
3%
Urinary tract infection
3%
Chills
3%
Tonsillitis
3%
Dizziness
3%
Oropharyngeal pain
3%
Pruritus
2%
Procedural pain
2%
Abdominal pain upper
2%
Diarrhoea
2%
Osteoarthritis
2%
Post vaccination fever
2%
Muscle spasms
1%
Appendicitis
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erenumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1 and 2 month later) on brain functioning.
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
859 Previous Clinical Trials
12,932,432 Total Patients Enrolled
4 Trials studying Migraine
102 Patients Enrolled for Migraine
Eli Lilly and CompanyIndustry Sponsor
2,679 Previous Clinical Trials
3,465,689 Total Patients Enrolled
27 Trials studying Migraine
10,521 Patients Enrolled for Migraine
Rami BursteinPrincipal Investigator - Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center