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

NCT ID: NCT06428838

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-30

Brief 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.

Conditions

Migraine; Chronic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

SoC will be delivered at the discretion of the treating physician

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

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.

Standard of Care + Eptinezumab

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

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: BIOLOGICAL

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

Standard of Care

Intervention Type: OTHER

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.

Interventions

Eptinezumab

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

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.

UNKNOWN

Sponsor Role: collaborator

Royal Columbian Hospital Foundation

OTHER

Sponsor Role: collaborator

Surrey Memorial Hospital

UNKNOWN

Sponsor Role: collaborator

Dr George Medvedev

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr George Medvedev

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Countries

Canada

Central Contacts

Julia Joyes Clinical Research Coordinator

Role: CONTACT

juliajoyes@healthtechconnex.com

778-735-1945

Facility Contacts

Vesna Ivkov

Role: primary

Vesna.Ivkov@fraserhealth.ca

Vesna Ivkov

Role: primary

vesna.ivkov@fraserhealth.ca

Other Identifiers

Medvedev_001

Identifier Type: -

Identifier Source: org_study_id