Real World Effectiveness of Eptinezumab in Participants With Migraine (EVEC)

May 9, 2023 updated by: H. Lundbeck A/S

An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Gilbert Neurology Partners/ CCT Research
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Ki Clinical Research LLC, dba New England Institute for Clinical Research
    • Florida
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Medical Group
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • The Headache Center
    • Missouri
      • North Kansas City, Missouri, United States, 64416
        • North Kansas City Hospital
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute - Amherst
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Women's Research and Wellness Center
    • Texas
      • Plano, Texas, United States, 75093
        • AIM Trials, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Olympus Family Medicine/CCT Research

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of migraine per International Headache Society (IHS) International Classification of Headache Disorder (ICHD)-3 guidelines at least 12 months prior to screening.
  • Have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records.
  • Be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known.
  • Be willing to accept randomization to any of the possible study medications if allocated to that treatment arm.
  • Be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application.

Exclusion Criteria:

  • The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients.
  • The participant has previous history of use of any of the study drugs (for example, eptinezumab, Botox, erenumab, fremanezumab or galcanezumab). Note that only previous Botox use for treatment of migraine is exclusionary. Prior use of Botox for cosmetic purposes is allowed.
  • The participant has a diagnosis of CM and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation.
  • The participant has used opioids or butalbital-containing products greater than 4 days per month in the last month.

Other inclusion and exclusion criteria may apply.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eptinezumab
Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84.
Drug: Eptinezumab
Concentrate for solution for IV infusion
Other Names:
  • Vyepti
Experimental: Anti-CGRP injectables
Participants are free to select treatment from one of 3 calcitonin gene-related peptide (CGRP) inhibitors: erenumab, fremanezumab, or galcanezumab. CGRP inhibitors will be administered via subcutaneous (SC) injection on Day 0 and then, per product label.
Drug: Erenumab
Solution for SC Injection
Other Names:
  • Aimovig®
Drug: Fremanezumab
Solution for SC Injection
Other Names:
  • Ajovy®
Drug: Galcanezumab
Solution for SC Injection
Other Names:
  • Emgality®
Experimental: Onabotulinumtoxin-A
Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84.
Drug: Onabotulinumtoxin-A
Solution for IM Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score
Time Frame: Baseline, Week 24
Baseline, Week 24
Number of "Good days" From Baseline
Time Frame: Up to Week 24
Up to Week 24
Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L)
Time Frame: Baseline, Week 24
Baseline, Week 24
Health Care Resources Utilization (HCRU)
Time Frame: Up to Week 24
Up to Week 24
QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score
Time Frame: Up to Week 24
Up to Week 24
QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score
Time Frame: Up to Week 24
Up to Week 24
Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: Week 24
Week 24
Percentage of Participants that Switch From the Preventive Medication they are Randomized to at Baseline to Another Preventive Medication
Time Frame: Week 24
Week 24

Collaborators and Investigators

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

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

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 (Actual)

March 4, 2022

Primary Completion (Actual)

February 17, 2023

Study Completion (Actual)

April 14, 2023

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19766N

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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