Investigating brain changes in migraine patients treated with erenumab
Registry for Migraine - Structural and Functional Magnetic Resonance Imaging Before and After Erenumab Treatment
This study looks at how a migraine prevention medication called erenumab affects the brain of people who have had migraines for over a year by using MRI scans before and after treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danish Headache Center Academic / other |
| Drugs / interventions | erenumab |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT04674020 on ClinicalTrials.gov |
What this trial studies
This study examines the structural and functional changes in the brain of migraine patients using magnetic resonance imaging (MRI) before and after treatment with erenumab, a medication designed to prevent migraines. The research focuses on individuals who have experienced migraines for at least a year and have a specific frequency of headache days. By analyzing MRI data, the study aims to provide insights into how erenumab affects the brain's structure and function in those suffering from migraines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of migraines for at least 12 months and a minimum of four migraine days per month.
Not a fit: Patients who developed migraines after the age of 50 or have a history of cluster headaches or hemiplegic migraines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of migraine treatment effects and lead to improved therapeutic strategies for patients.
How similar studies have performed: Other studies have shown promising results in understanding migraine treatments, but this specific approach using MRI with erenumab is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Criteria: Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study-specific activities/procedures * Age greater than or equal to 18 years upon entry into screening * History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report * Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening after baseline period * Must have demonstrated greater than or equal to 75% compliance in headache diary usage during baseline period Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: Disease Related * Greater than 50 years of age at migraine onset * History of cluster headache or hemiplegic migraine headache * Inability to differentiate between migraine from other headaches * The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Prior/Concomitant Therapy * Previously received erenumab (Aimovig®) * Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period Prior/Concurrent Clinical Study Experience * Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study (ies). Other investigational procedures while participating in this study are excluded. Other Exclusions * Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test. * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product. * Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. * Evidence of current pregnancy or breastfeeding per subject self-report or medical records * Subject has known sensitivity to any of the products or components to be administered during dosing * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge Contraindications to MRI: * Does not wish to be informed about unexpected MRI findings * Severe claustrophobia * Implanted magnetic material including pacemaker, prothesis, metal-clips, etc. * Insulin pump which cannot be removed * Magnetic foreign object in the body * Surgical intervention within 6 weeks prior to MRI
Where this trial is running
Copenhagen
- Danish Headache Center — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Messoud Ashina, MD — Danish Headache Center
- Study coordinator: Messoud Ashina, MD
- Email: ashina@dadlnet.dk
- Phone: +45 38 63 33 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.