Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action

NCT04271202 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019P001081
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (6)

• Change in Gray Matter Thickness in the Somatosensory Cortex

  Measure difference in gray matter thickness (as measured in MRI images) in study time frame

  baseline MRI (day 0), treatment effect MRI (day 90)

• Change in Gray Matter Thickness in Right Frontal Cortex

  Measure difference in gray matter thickness (as measured in MRI images) in study time frame

  baseline MRI (day 0), treatment effect MRI (day 90)

• Change in Gray Matter Thickness in Right Supra Marginal Cortex

  Measure difference in gray matter thickness (as measured in MRI images) in study time frame

  baseline MRI (day 0), treatment effect MRI (day 90)

• Change in Gray Matter Thickness in Left Frontal Cortex

  Measure difference in gray matter thickness (as measured in MRI images) in study time frame

  baseline MRI (day 0), treatment effect MRI (day 90)

• Change in Gray Matter Thickness in the Left Superior Frontal Gyrus

  Measure difference in gray matter thickness (as measured in MRI images) in study time frame

  baseline MRI (day 0), treatment effect MRI (day 90)

• Change in Gray Matter Thickness in the Left Medial Superior Frontal Gyrus

  Measure difference in gray matter thickness (as measured in MRI images) in study time frame

  baseline MRI (day 0), treatment effect MRI (day 90)

Study Arms (1)

Treatment

OTHER

Effects of galacenezumab (emgality) treatment (injectable 240 mg initial dose followed by 120 mg treatments 1 and 2 month later) on brain functioning.

Drug: Emgality 120 MG in 1 ML Prefilled Syringe

Interventions

Emgality 120 MG in 1 ML Prefilled Syringe DRUG

Initial dose of 240 mg followed by 2 interventions (1 month apart) of 120 mg - all given as injectables.

Also known as: Galcanezumab

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 65 years
• Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 (International Classification of Headache Disorders) criteria
• 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
• Onset of migraine at age 50 years or younger
• Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than migraine that may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
• Able to provide written informed consent

You may not qualify if:

• Currently on a regimen of 1 or more migraine preventative therapy
• Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that may confound the study assessments
• Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)
• 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)
• Abnormal baseline electrocardiogram (ECG) within the last year (e.g., second or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
• Uncontrolled high blood pressure (systolic \>160 mm Hg, diastolic \>100 mm Hg) after 3 measurements within 24 hours
• Known history or suspicion of secondary headache
• Known history or suspicion of substance abuse or addiction (within the last 5 years)
• Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 1 year
• Currently takes simple analgesics or NSAIDs \>15 days per month or triptans, ergots, or combined analgesics \>10 days per month for headaches or other body pain
• Currently takes prescription opioids for headaches or body pain
• Undergone nerve block (occipital or other) in the head or neck within the last 3 months
• Received botulinum toxin or anti-CGRP-mAb injections within the last 6 months
• Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
• Participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Pain Clinic at Beth Israel Deaconess Medical Center

Brookline, Massachusetts, 02445, United States

Location

Related Publications (1)

• Ashina S, Melo-Carrillo A, Toluwanimi A, Bolo N, Szabo E, Borsook D, Burstein R. Galcanezumab effects on incidence of headache after occurrence of triggers, premonitory symptoms, and aura in responders, non-responders, super-responders, and super non-responders. J Headache Pain. 2023 Mar 16;24(1):26. doi: 10.1186/s10194-023-01560-x.

  PMID: 36927366 DERIVED

MeSH Terms

Interventions

erenumab; galcanezumab

Results Point of Contact

• Title: Rami Burstein
• Organization: BIDMC

rburstei@bidmc.harvard.edu

617 584 1794

Study Officials

• Rami Burstein

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: July 29, 2020
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)