Emgality for Migraine Prevention

Palo Alto (17 mi)

Overseen byRami Burstein

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to understand better the mechanisms of action of calcitonin gene related peptide (CGRP) targeted monoclonal antibodies in migraine prevention. Specifically, the protocol will allow the investigators to determine whether the main site of action of this novel and recently-approved class of migraine prophylactic drugs act inside or outside the brain and if so, where.

Eligibility Criteria

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.

Inclusion Criteria

I have 10-25 headache days a month, with at least 8 being long-lasting migraines.

I have been diagnosed with migraine, following official guidelines.

I am between 18 and 65 years old.

My migraines started when I was 50 or younger.

Exclusion Criteria

My blood pressure is not higher than 160/100 mm Hg.

I have had botulinum toxin or anti-CGRP-mAb injections in the past 6 months.

I have used marijuana or CBD oil in the past year.

I do not have severe heart problems like heart failure or a past heart attack.

I have had a nerve block in my head or neck in the last 3 months.

I have or might have headaches caused by another health condition.

I have had a stroke, TIA, or surgery on the arteries in my neck.

I regularly take painkillers or specific headache medicines more than half the month.

I am currently taking prescription opioids for pain.

I do not have other major pain issues that could affect the study's results.

I am currently taking medication to prevent migraines.

Treatment Details

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.

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.

Galcanezumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Emgality for: