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

May 22, 2024 updated by: Dr George Medvedev

Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital
        • Contact:
        • Principal Investigator:
          • George Medvedev Neurologist, MD
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Surrey Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Dr George Medvedev Neurologist, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard of Care
SoC will be delivered at the discretion of the treating physician
Other: 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.
Experimental: 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).
Other: 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.
Biological: Eptinezumab
The study treatment consists of a single infusion of eptinezumab (100mg/mL).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of migraine days at week 1
Time Frame: Baseline to Week 1
Number of migraine days at week 1, as reported in daily Headache Diary
Baseline to Week 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission to the Emergency Department (ED)
Time Frame: Baseline to Month 3
Readmission to the Emergency Department (ED) as assessed by patient chart
Baseline to Month 3
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: Baseline to Month 3
The Generalized Anxiety Disorder 7-item (GAD-7) will be assessed at baseline, month 1 and month 3. The GAD-7 is a short self-report questionnaire assessing the severity of anxiety disorder. For each item, the participant is asked how bothered they have been by the problem in the last 2 weeks. The total score ranges from 0-21, and a score greater than 15 indicates severe anxiety. The recall period for the GAD-7 is 2 weeks.
Baseline to Month 3
Headache Impact Test (HIT-6)
Time Frame: Baseline to Month 3
The Headache Impact Test (HIT-6) will involve an assessment at baseline and at months 1 and 3. The HIT-6 (v1.0) is a Likert-type, self-reported questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The assessment was developed to measure a wide spectrum of factors contributing to headache burden, and it has demonstrated reliability and validity. The recall period for the HIT-6 is 4 weeks.
Baseline to Month 3
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline to Month 3
The PHQ-9 is a short self-report questionnaire assessing signs and symptoms of depression. The questionnaire consists of nine items which ask about the frequency and severity of depressive symptoms based on DSM-IV criteria. For each item, the participant is asked to rate the severity of the symptom on a scale from 0 to 3. The total score ranges from 0-27 with a higher score indicating more severe depressive symptoms. The recall period for the PHQ-9 is 2 weeks.
Baseline to Month 3
Patient Global Impression of Change (PGI-C)
Time Frame: Baseline to Month 3
The PGI-C will involve an assessment at 24-72hrs, week 1, month 1 and month 3. PGI-C is a one-item measure rating of the overall patient perceived improvement on a seven-point scale. Patients rate their change since treatment initiation as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse.
Baseline to Month 3
Number of monthly headache days
Time Frame: Baseline to Month 3
Number of monthly headache days as assessed by the Migraine Disability Assessment (MIDAS)
Baseline to Month 3
Migraine recurrence
Time Frame: Baseline to Month 3
Recurrence of migraine as reported in daily Headache Diary
Baseline to Month 3
Work Productivity and Activity Impairment (WPAI)
Time Frame: Baseline to Month 3
The WPAI is a six-item validated instrument that measures aspects of work productivity and activity impairment due to migraine over the past 7 days with higher values, in the form of percentages, indicating greater impairment due to the respondent's health. Only patients that are currently employed (full-time, part-time, or self-employed) are eligible to respond to the items assessing work-related activities. Item 6 in the WPAI will be administered to those not in employment, providing the possibility of calculating activity impairment for patients that are not employed. The six items are used to derive four subscales: Absenteeism (proportion of missed work hours out of the total; scale 0-100%), Presenteeism (level of work impairment; scale 0-10), Overall work impairment (combination of absenteeism and presenteeism; scale 0-100%), and Activity impairment (impairment in daily activities; scale 0-10).
Baseline to Month 3
Sleep Quality
Time Frame: Baseline to Month 3
Sleep quality will be assessed with the question, "On average, about how many hours of sleep do you get per night?" with responses including "7-9 hrs", "6-6.9 hrs", "5-5.9 hrs" or "less than 5 hrs". The recall period will be 1 week.
Baseline to Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr George Medvedev

Collaborators

H. Lundbeck A/S
Royal Columbian Hospital
Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.
Surrey Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medvedev_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If the results of the study are published in the public domain, only aggregate/group data will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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