Using CGRP sensitivity to predict migraine prevention with Erenumab
Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
PHASE4 · Danish Headache Center · NCT04592952
This study is testing if how sensitive someone is to a certain protein can help predict if Erenumab will effectively prevent their migraines.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Danish Headache Center (other) |
| Drugs / interventions | erenumab |
| Locations | 1 site (Copenhagen, Glostrup) |
| Trial ID | NCT04592952 on ClinicalTrials.gov |
What this trial studies
This study investigates how sensitivity to calcitonin gene-related peptide (CGRP) can predict the effectiveness of Erenumab in preventing migraines. It involves a single-center, open-label approach where adults with episodic or chronic migraines will first receive an intravenous infusion of CGRP, followed by a 24-week treatment with Erenumab. Participants will be monitored for their response to treatment, allowing researchers to assess the relationship between CGRP sensitivity and migraine prevention outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of migraines and at least four migraine days per month.
Not a fit: Patients who 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 lead to more personalized and effective migraine prevention strategies for patients.
How similar studies have performed: Other studies have explored CGRP's role in migraine treatment, but this specific predictive approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years of age upon entry into screening * History of migraine with or without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria * ≥ 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening * Subject has provided informed consent prior to initiation of any study-specific activities/procedures. * Must have demonstrated greater than or equal to 75% compliance in Headache Diary usage during the 4-week run-period prior to Day 1 of the open-label treatment phase. Exclusion Criteria: * \> 50 years of age at migraine onset * History of cluster headache or hemiplegic migraine * Inability to differentiate migraine from other headaches * The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion * Previously received erenumab (Aimovig) * Received anti-CGRP monoclonal antibody within 3 months prior to the CGRP-infusion * 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. * Female subjects of childbearing potential with a positive pregnancy test during any study visit * Female subject is pregnant or breastfeeding or planning to become pregnant during the study * Evidence of current pregnancy or breastfeeding * Female subject of childbearing potential unwilling to use an acceptable method of effective contraception * Hypertension on the experimental day defined as systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg * Hypotension on the experimental day defined as systolic blood pressure \< 90mmHg or diastolic blood pressure \< 50mmHg * Any headache (including migraine) within 24 hours prior to the start of the CGRP-infusion * Intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the CGRP-infusion * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge
Where this trial is running
Copenhagen, Glostrup
- Danish Headache Center — Copenhagen, Glostrup, Denmark (RECRUITING)
Study contacts
- Principal investigator: Messoud Ashina, MD — Danish Headache Center
- Study coordinator: Messoud Ashina, MD
- Email: ashina@dadlnet.dk
- Phone: +4538633385
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.
Conditions: Migraine