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

NCT06428838 | Not Yet Recruiting Phase 3

• 1 other identifier: Medvedev_001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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

Keywords

acute treatment; emergency; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Number of migraine days at week 1

  Number of migraine days at week 1, as reported in daily Headache Diary

  Baseline to Week 1

Secondary Outcomes (9)

• Readmission to the Emergency Department (ED)

  Baseline to Month 3

• Generalized Anxiety Disorder 7-item (GAD-7)

  Baseline to Month 3

• Headache Impact Test (HIT-6)

  Baseline to Month 3

• Patient Health Questionnaire (PHQ-9)

  Baseline to Month 3

• Patient Global Impression of Change (PGI-C)

  Baseline to Month 3

Study Arms (2)

Standard of Care

OTHER

SoC will be delivered at the discretion of the treating physician

Other: Standard of Care

Standard of Care + Eptinezumab

EXPERIMENTAL

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

Biological: Eptinezumab; Other: Standard of Care

Interventions

Eptinezumab BIOLOGICAL

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

Standard of Care + Eptinezumab

Standard of Care 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; Standard of Care + Eptinezumab

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
• Provided signed informed consent;
• Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.

You may not qualify if:

• Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
• Current or history of severe cardiovascular disease or renal dysfunction
• A systemic condition in the stage of active treatment (vasculitis, etc.)
• Pregnant or at risk of becoming pregnant (absent contraception)
• Currently enrolled in another investigational drug trial
• Dosed with eptinezumab within the past 3 months
• Currently on anti-CGRP therapy with monoclonal antibodies
• Currently involved in active litigation
• Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity
• Hypersensitivity to the active substance or to any of the excipients

Sponsors & Collaborators

• Dr George Medvedev: lead
• H. Lundbeck A/S: collaborator
• Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.: collaborator
• Royal Columbian Hospital Foundation: collaborator
• Surrey Memorial Hospital: collaborator

Study Sites (2)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

Location

MeSH Terms

Conditions

Migraine Disorders; Emergencies

Interventions

eptinezumab; Standard of Care

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Julia Joyes Clinical Research Coordinator

CONTACT

778-735-1945; juliajoyes@healthtechconnex.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized (1:1), controlled trial with standard of care (SoC) as control arm.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 24, 2024
• Study Start: September 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)