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Clinical Trials in Canada / NCT06428838
Enrolling by invitation Phase 3

Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context

NCT06428838 · tracked via the Priya Life Science Canada tracker
Sponsor
Dr George Medvedev
Phase
Phase 3
Started
2025-05-05
Last updated
2026-09-30

Condition(s) studied

MigraineChronic Migraine

Investigational drug(s) / intervention(s)

Eptinezumab →Standard of Care

Eptinezumab: The study treatment consists of a single infusion of eptinezumab (100mg/mL).

Standard of Care: SoC may include a combination of Toradol, Metoclopramide, and/or Benadryl. Ketamine and/or Midazolam may also be used, according to a stepwise approach, at the discretion of the treating physician. The timing and dose of all medication(s) administered in the ED will be recorded.

Study summary

The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED.

Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term.

Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies.

This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.

Eligibility

Sex
ALL
Min age
19 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ED or known from the patient's chart; 2. Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria; 3. Provided signed informed consent; 4. Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English. Exclusion Criteria: 1. Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor 2. Current or history of severe cardiovascular disease or renal dysfunction 3. A systemic condition in the stage of active treatment (vasculitis, etc.) 4. Pregnant or at risk of becoming pregnant (absent contraception) 5. Currently enrolled in another investigational drug trial 6. Dosed with eptinezumab within the past 3 months 7. Currently on anti-CGRP therapy with monoclonal antibodies 8. Currently involved in active litigation 9. Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity 10. Hypersensitivity to the active substance or to any of the excipients

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Royal Columbian Hospital New Westminster British Columbia
Surrey Memorial Hospital Surrey British Columbia

Other trials for the same condition

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults Active, not recruiting
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial Recruiting
Study of EVO756 in Adults With Migraine Recruiting
Evaluation of a Mind-Body Based Approach for Chronic Pain Treatment Starting soon
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06428838 on ClinicalTrials.gov ↗ ← All trials in Canada