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

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Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Migraine; Migraine

Treatments: Other: Standard of Care; Biological: Eptinezumab

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06428838

Medvedev_001

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Standard of Care

Other group

Description:

SoC will be delivered at the discretion of the treating physician

Treatment:

Other: Standard of Care

Standard of Care + Eptinezumab

Experimental group

Description:

In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL).

Treatment:

Other: Standard of Care

Biological: Eptinezumab