← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month before and 3 months after treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

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

Select...

I have been diagnosed with migraine, following official guidelines.

Select...

I am between 18 and 65 years old.

Select...

My migraines started when I was 50 or younger.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month before and 3 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual Cortex

Change in abnormal brain functioning - food deprivation

Change in abnormal brain functioning - light sensitivity

+5 more

Side effects data

From 2023 Phase 4 trial • 701 Patients • NCT04084314

35%

COVID-19

19%

Nasopharyngitis

15%

Constipation

Fatigue

Hypertension

Immunisation reaction

Headache

Migraine

Back pain

Depression

Nausea

Arthralgia

Vertigo

Alopecia

Pain in extremity

Tonsillitis

Cystitis

Urinary tract infection

Oropharyngeal pain

Pruritus

Dizziness

Pyrexia

Cough

Chills

Diarrhoea

Abdominal pain upper

Muscle spasms

Osteoarthritis

Procedural pain

Post vaccination fever

Appendicitis

Intervertebral disc protrusion

100%

80%

60%

40%

20%

Study treatment Arm

Erenumab

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

838 Previous Clinical Trials

13,010,428 Total Patients Enrolled

3 Trials studying Migraine

92 Patients Enrolled for Migraine

Eli Lilly and CompanyIndustry Sponsor

2,622 Previous Clinical Trials

3,216,711 Total Patients Enrolled

27 Trials studying Migraine

10,528 Patients Enrolled for Migraine

Rami BursteinPrincipal Investigator - Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to join this experiment?

"This research initiative is looking for 120 participants with the diagnosis of sick headache, between the ages 18 and 65."

Answered by AI

Is this an innovative clinical trial?

"Currently, 6 dynamic trials for this treatment exist in 141 cities and 11 countries. The pilot study, bankrolled by Eli Lilly and Company commenced in 2018 with 325 participants undergoing Phase 3 drug approval stages. Since then, an additional 20 experiments have been conducted."

Answered by AI

What is the maximum capacity for inclusion in this experiment?

"Affirmative. Inquiry of clinicaltrials.gov reveals that the study, which was initially made available on July 29th 2020, is still recruiting for 120 patients from a single center. The most recent update to this trial occurred on October 31st 2022."

Answered by AI

Does this trial encompass individuals who are fifty years or older?

"This research requires participants to be of legal age and under the senior citizen demographic."

Answered by AI

What potential harm could patients incur from this treatment?

"Based on the fact that this treatment has reached Phase 4, there is a large amount of data showing its safety which resulted in it receiving a score of 3."

Answered by AI

To what extent have researchers looked into this treatment in the past?

"Currently, 6 medical studies involving this intervention are running with 2 of them in their final Phase 3 stage. Most of the trials take place within Brookline, Massachusetts; however, across 330 sites there are investigations into this new treatment."

Answered by AI

Are there still opportunities available to join this trial?

"The clinical trial is open to recruitment, as evidenced by the data on clinicaltrials.gov; first advertised on July 29th 2020 and most recently updated October 31st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action

Rami Burstein 2020. "Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04271202.

All > Migraine Headaches > Migraine