Migraine Nervous System Diseases
Conditions
Interventions
Patients presenting to the Emergency Department at St Mary’s Hospital with a migraine attack lasting more than 72 hours will receive a single 300 mg intravenous dose of eptinezumab over 30 minutes. Cr
Sponsors
Centre Hospitalier de l’Université de Montréal
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 29/05/2026: 1. Adults over 18 years of age with at least 4 monthly migraine days, who present to the emergency department for a migraine attack lasting more than 72 hours 2. Pain reported by the patient (on a numeric scale 0 to 10) = 6 out of 10 3. Patient who speaks and understands English or French Previous inclusion criteria: 1. Adults over 18 years of age 2. At least 4 monthly migraine days 3. Who present to the emergency department with a migraine attack lasting more than 72 hours
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 29/05/2026: 1. Contraindications to eptinezumab according to the product monograph 2. Current pregnancy, breastfeeding, or plans to become pregnant within the next 5 months 3. Treatment with Botox or another anti-CGRP therapy (galcanezumab, erenumab, fremanezumab, atogepant, eptinezumab) within the past year 4. Uncontrolled cardiovascular risk factors or active cardiovascular disease (hypertension, diabetes, Raynaud’s phenomenon, cerebrovascular accident, cardiomyopathy, myocardial infarction) 5. Uncontrolled psychiatric illness 6. Immunodeficiency 7. Autoimmune disease 8. Return visits for patients already enrolled in the study Previous exclusion criteria: 1. Contraindications to eptinezumab as per the product monograph 2. Current pregnancy, breastfeeding, or planned pregnancy within the next 5 months 3. Preventive treatment received within the past year: onabotulinumtoxinA or another anti-CGRP agent 4. Uncontrolled cardiovascular risk factors or active cardiovascular disease (ischemic heart disease, angina, recent stroke) 5. Raynaud’s disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome as of 01/06/2026: 1. Percentage of patients reporting pain relief from status migrainosus measured using a four-point intensity scale at T+120 (120 minutes post-infusion) Previous primary outcomes: 1. Percentage of patients reporting pain relief from status migrainosus measured using a four-point intensity scale at T+120 (120 minutes post-infusion) 2. Percentage of patients reporting the absence of their most bothersome associated symptom of status migrainosus measured using a yes/no questionnaire at T+120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 01/06/2026: 1. Percentage of patients reporting complete pain freedom measured using a four-point intensity scale at T+120 2. Perceived improvement measured using the Patient Global Impression of Change (PGIC) scale at T+120 3. Percentage of patients receiving a rescue migraine treatment measured using the patient’s chart in the pharmacological profile section between T+120 and medical discharge from ED 4. Number of patients requiring a neurology consultation in the emergency department measured using the patient’s chart in the medical observations section at one timepoint 5. Percentage of patients reporting a =50% reduction from baseline in the number of monthly migraine days (MMDs) measured using the application Canadian Migraine Tracker by the Canadian Headache Society, averaged over Weeks 1 through 12 6. Perceived improvement measured using the Patient Global Impression of Change (PGIC) scale at 12 weeks following eptinezumab infusion 7. Migraine interictal burden score measured using the Migraine Interictal Burden Scale (MIBS-4) questionnaire at baseline and 12 weeks following eptinezumab infusion 8. Number of patients returning to the emergency department for migraine within 12 weeks following eptinezumab infusion, measured using data collected from patient medical records at one timepoint 9. Percentage of patients reporting the absence of their most bothersome associated symptom of status migrainosus measured using a yes/no questionnaire at T+120 10. Consent rate, proportion of participants receiving the complete infusion, adherence to procedures in the emergency department, data completeness, retention rate at follow-up and recruitment speed, measured using reporting from clinical staff and chart review on day 1 of emergency department visit and T12weeks post infusion 11. Reasons for refusal or interruption measured using feedback from clinical staff and an acceptability questionnaire on day 1 of emergency department visit | — |
Countries
Canada
Contacts
Public ContactMarzieh Eghtesadi
Outcome results
None listed