Eptinezumab for the acute treatment of status migraine
| ISRCTN | ISRCTN59164978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59164978 |
| Sponsor | Centre Hospitalier de l’Université de Montréal |
| Funder | H. Lundbeck A/S |
- Submission date
- 31/10/2025
- Registration date
- 04/11/2025
- Last edited
- 29/05/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Migraines are a frequent reason for emergency department (ED) visits due to the significant disability they cause and the associated symptoms such as nausea, vomiting, dehydration, and hypersensitivity to light and sound. The current standard of care in Quebec hospitals includes intravenous hydration and administration of an intravenous antiemetic, usually metoclopramide, a non-specific migraine treatment that often causes side effects, including drowsiness, dizziness, and akathisia. As a result, patients often spend several hours in the ED before experiencing relief; few patients report complete relief at discharge, and one in four return for unresolved or recurrent migraine.
The recent introduction of monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) represents a major advancement in migraine management. This is the first class of medications specifically designed for the disease. Four anti-CGRP agents are currently approved and publicly reimbursed in Quebec for migraine prevention: galcanezumab, fremanezumab, atogepant, and eptinezumab. Eptinezumab is the only preventive agent that has also demonstrated a rapid onset of action in clinical trials. However, its effectiveness has not yet been studied for treating severe and prolonged migraine attacks in patients presenting to the emergency department.
The study hypothesis is that the dual action of eptinezumab, both acute and preventive, could significantly improve migraine relief and associated symptoms in the ED. It is also anticipated that there will be a reduction in the frequency of migraine attacks during the three months following the emergency visit, due to eptinezumab’s previously demonstrated preventive effect.
Who can participate?
Adults aged 18 years and over who have at least 4 migraine days per month.
What does the study involve?
This is a prospective, interventional, single-center study to evaluate the effectiveness of eptinezumab for the treatment of status migrainosus when administered in the ED of a community hospital (St. Mary’s Hospital). All patients will be offered follow-up at the tertiary headache center of the Montreal University Health Center (CHUM). A telephone follow-up will be done 1 week after discharge from the ED to increase study retention and monitor for drug adverse events.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
All patients will be followed up at the tertiary headache center of the Centre Hospitalier de l’Université de Montréal (CHUM).
When is the study starting and how long is it expected to run for?
July 2026 to April 2027
Who is funding the study?
H. Lundbeck A/S (Denmark)
Who is the main contact?
Marzieh Eghtesadi, marzieh.eghtesadi.med@ssss.gouv.qc.ca
Contact information
Public, Scientific, Principal investigator
CHUM 1000 St Denis
Montreal
H2X0C1
Canada
 ORCID ID |
0000-0003-0409-0421 |
|---|---|
| Phone | +1 5148908000 |
| marzieh.eghtesadi@mail.mcgill.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-center prospective unblinded study |
| Secondary study design | Non randomised study |
| Scientific title | Eptinezumab for the acute treatment of status migrainosus in the emergency department of a community hospital |
| Study acronym | ED-RELIEF |
| Study objectives | To evaluate the effectiveness of eptinezumab for the acute treatment of status migrainosus in the emergency department. |
| Ethics approval(s) |
Approved 30/07/2025, Research Center of the Montreal University Health Center (CHUM - Pavillon R 900, rue St-Denis, Montreal, H2X 0A9, Canada; +1-514-890-8000; soutien.rc.chum@ssss.gouv.qc.ca), ref: MP-02-2026-13088 |
| Health condition(s) or problem(s) studied | Migraine |
| Intervention | 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. Criteria related to acute migraine relief will be assessed using the Questionnaire to be completed by the ED physician, administered by emergency physicians. Patients will be advised to document their migraine frequency using the Canadian Migraine Tracker and evaluated 12 weeks after the infusion at the tertiary headache clinic of the Montreal University Health Center for the study’s secondary outcomes related to eptinezumab’s preventative effect, so that it may be represcribed by the physician if beneficial to the patient after completing a provincial reimbursement formulary. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Eptinezumab (Vypeti) |
| Primary outcome measure(s) |
1. Percentage of patients reporting pain relief from status migrainosus measured using a four-point intensity scale at T+120 (120 minutes post-infusion) |
| Key secondary outcome measure(s) |
1. Percentage of patients reporting complete pain freedom measured using a four-point intensity scale at T+120 |
| Completion date | 01/04/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 47 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2026 |
| Date of final enrolment | 01/12/2026 |
Locations
Countries of recruitment
- Canada
Study participating centres
Montreal
H2X 0C1
Canada
Montreal
H3T 0A2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 04/11/2025 | No | No |
Additional files
Editorial Notes
29/05/2026: The following changes were made to the study record:
1. The Phase was changed from IV to III.
2. The target sample size was changed from 45 to 47.
3. The inclusion and exclusion criteria were updated.
4. The completion date was changed from 01/01/2027 to 01/04/2027.
07/05/2026: The following changes were made to the study record:
1. The date of first enrolment was changed from 01/01/2026 to 01/07/2026.
2. The date of final enrolment was changed from 01/07/2026 to 01/12/2026.
04/11/2025: Study's existence confirmed by the Research Center of the Montreal University Health Center, Canada.
