Clincosm LogoSign in Get a demo

EVEC: Real World Effectiveness of Eptinezumab in Participants With Migraine

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05284019
Collaborator
(none)
200
Enrollment
1
Location
3
Arms
15.9
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States
Actual Study Start Date :
Mar 4, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score [Baseline, Week 24]

    2. Number of "Good days" From Baseline [Up to Week 24]

    3. Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) [Baseline, Week 24]

    4. Health Care Resources Utilization (HCRU) [Up to Week 24]

    5. QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score [Up to Week 24]

    6. QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score [Up to Week 24]

    7. Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) [Week 24]

    8. Percentage of Participants that Switch From the Preventive Medication they are Randomized to at Baseline to Another Preventive Medication [Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Headache Center Ridgeland Mississippi United States 39157

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT05284019
    Other Study ID Numbers:
    • 19766N
    First Posted:
    Mar 17, 2022
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    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
    Additional relevant MeSH terms:
    Migraine Disorders
    Erenumab
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Mar 17, 2022