A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications

September 7, 2026 updated by: H. Lundbeck A/S

Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies

The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

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
      • Phoenix, Arizona, United States, 85013-4409
        • St. Joseph's Hospital and Medical Center-Barrow Neurological Institute - Barrow Brain Tumor Resea...
      • Phoenix, Arizona, United States, 85054-4502
        • Mayo Clinic - Vascular Center - Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-6355
        • Baptist Health Center for Clinical Research (BHCCR)
    • California
      • San Marcos, California, United States, 92069
        • The Neuron Clinic - Escondido
      • Walnut Creek, California, United States, 94549-4500
        • Sunwise Clinical Research, LLC
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Hasbani Neurology - New Haven
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Neurology and Headache (NEINH) - Stamford
    • Florida
      • Miami, Florida, United States, 33176
        • Brainstorm Research, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60657-9269
        • Chicago Headache Center and Research Institute - Chicago
    • Louisiana
      • Chalmette, Louisiana, United States, 70043-1668
        • Crescent City Headache and Neurology Center
    • Massachusetts
      • Foxborough, Massachusetts, United States, 02035
        • Neurology Center of New England, PC
      • Westborough, Massachusetts, United States, 01581
        • Mass Institute of Clinical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Michigan Headache & Neurological Institute (MHNI)
    • New York
      • Albany, New York, United States, 12208-3412
        • Albany Medical College
      • Amherst, New York, United States, 14226-1727
        • Dent Neurosciences Research Center
      • Port Jefferson Station, New York, United States, 11776
        • North Suffolk Neurology - Port Jefferson Station
    • North Carolina
      • Greensboro, North Carolina, United States, 27405-6962
        • Headache Wellness Center
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • C7 Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5563
        • Thomas Jefferson University Hospital - Breast Care Center
      • Pittsburgh, Pennsylvania, United States, 15236-4604
        • Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Road
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • KCA Neurology, PLLC

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

Key Inclusion Criteria:

  • The participant has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) guidelines with a history of migraine of at least 12 months prior to the Screening Visit.
  • The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
  • The participant has documented evidence of recent inadequate response to either one anti-CGRP monoclonal antibody (mAb) (other than eptinezumab) or one gepant, indicated and used for migraine prevention.

Key Exclusion Criteria:

  • The participant has taken more than 10 tablets of ubrogepant or more than 8 tablets of rimegepant per month as an acute migraine medication in the 1 month prior to the screening visit and during the 4-week baseline period.
  • The participant has previously had an inadequate response to more than one CGRP-targeting therapy (anti-CGRP mAb or gepants), indicated for migraine prevention.
  • The participant has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of eptinezumab. Male participants with abnormal prostate-specific antigen levels according to national/local guideline may be enrolled in the trial provided they have been followed up, have been asymptomatic, and have had no treatment for prostate cancer. Participants under surveillance for a low and stable level of M-component are allowed.
  • The participant has previously been treated with eptinezumab.

Other protocol-defined inclusion and exclusion criteria 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eptinezumab
Participants will receive eptinezumab at Baseline (Day 1) and Week 12
Drug: Eptinezumab
Solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Scale
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Monthly Migraine Days (MMDs)
Time Frame: Weeks 1-12 and 13-24
Weeks 1-12 and 13-24
Change from Baseline in the Percentage of MMDs with Severe Pain Intensity
Time Frame: Weeks 1-12 and 13-24
Weeks 1-12 and 13-24
Change from Baseline in Monthly Headache Days (MHDs)
Time Frame: Weeks 1-12 and 13-24
Weeks 1-12 and 13-24
Change from Baseline in MMDs with Use of Acute Medication
Time Frame: Weeks 1-12 and 13-24
Weeks 1-12 and 13-24
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale
Time Frame: Week 12
Week 12
PGIC Score
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Change from Baseline in Migraine Disability Assessment (MIDAS) Scores
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Goal Attainment Scaling (GAS) Score
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Number of Participants with GAS Score ≥50
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Change from Baseline in Number of Good Days per Month
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Brain Fog Score
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Clinical Global Impression of Change (CGIC) Scale
Time Frame: Weeks 12 and 24
Weeks 12 and 24
CGIC Score
Time Frame: Weeks 12 and 24
Weeks 12 and 24
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Week 26
Up to Week 26

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, HQ_Medinfo@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)

December 18, 2024

Primary Completion (Actual)

September 2, 2026

Study Completion (Actual)

September 2, 2026

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20668A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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