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

Primary Purpose

Migraine

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Eptinezumab

Erenumab

Onabotulinumtoxin-A

Fremanezumab

Galcanezumab

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gilbert Neurology Partners/ CCT Research
Ki Clinical Research LLC, dba New England Institute for Clinical Research
Innovation Medical Group
The Headache Center
North Kansas City Hospital
StudyMetrix Research
Dent Neurologic Institute - Amherst
Carolina Women's Research and Wellness Center
AIM Trials, LLC
Olympus Family Medicine/CCT Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Eptinezumab

Anti-CGRP injectables

Onabotulinumtoxin-A

Arm Description

Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84.

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.

Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84.

Outcomes

Primary Outcome Measures

Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score

Number of "Good days" From Baseline

Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L)

Health Care Resources Utilization (HCRU)

QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score

QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score

Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

Percentage of Participants that Switch From the Preventive Medication they are Randomized to at Baseline to Another Preventive Medication

Secondary Outcome Measures

Full Information

NCT ID

NCT05284019

First Posted

February 23, 2022

Last Updated

May 9, 2023

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT05284019

Brief Title

Real World Effectiveness of Eptinezumab in Participants With Migraine

Acronym

EVEC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated due to enrolment challenges.

Study Start Date

March 4, 2022 (Actual)

Primary Completion Date

February 17, 2023 (Actual)

Study Completion Date

April 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eptinezumab

Arm Type

Experimental

Arm Description

Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84.

Arm Title

Anti-CGRP injectables

Arm Type

Experimental

Arm Description

Arm Title

Onabotulinumtoxin-A

Arm Type

Experimental

Arm Description

Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84.

Intervention Type

Drug

Intervention Name(s)

Eptinezumab

Other Intervention Name(s)

Vyepti

Intervention Description

Concentrate for solution for IV infusion

Intervention Type

Drug

Intervention Name(s)

Erenumab

Other Intervention Name(s)

Aimovig®

Intervention Description

Solution for SC Injection

Intervention Type

Drug

Intervention Name(s)

Onabotulinumtoxin-A

Intervention Description

Solution for IM Injection

Intervention Type

Drug

Intervention Name(s)

Fremanezumab

Other Intervention Name(s)

Ajovy®

Intervention Description

Solution for SC Injection

Intervention Type

Drug

Intervention Name(s)

Galcanezumab

Other Intervention Name(s)

Emgality®

Intervention Description

Solution for SC Injection

Primary Outcome Measure Information:

Title

Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score

Time Frame

Baseline, Week 24

Title

Number of "Good days" From Baseline

Time Frame

Up to Week 24

Title

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

Title

Health Care Resources Utilization (HCRU)

Time Frame

Up to Week 24

Title

QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score

Time Frame

Up to Week 24

Title

QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score

Time Frame

Up to Week 24

Title

Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

Time Frame

Week 24

Title

Percentage of Participants that Switch From the Preventive Medication they are Randomized to at Baseline to Another Preventive Medication

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Email contact via H. Lundbeck A/S

Organizational Affiliation

LundbeckClinicalTrials@Lundbeck.com

Official's Role

Study Director

Facility Information:

Facility Name

Gilbert Neurology Partners/ CCT Research

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85297

Country

United States

Facility Name

Ki Clinical Research LLC, dba New England Institute for Clinical Research

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Innovation Medical Group

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

The Headache Center

City

Ridgeland

State/Province

Mississippi

ZIP/Postal Code

39157

Country

United States

Facility Name

North Kansas City Hospital

City

North Kansas City

State/Province

Missouri

ZIP/Postal Code

64416

Country

United States

Facility Name

StudyMetrix Research

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63303

Country

United States

Facility Name

Dent Neurologic Institute - Amherst

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Carolina Women's Research and Wellness Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

AIM Trials, LLC

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Olympus Family Medicine/CCT Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Real World Effectiveness of Eptinezumab in Participants With Migraine

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