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

Last updated: May 11, 2026
Sponsor: H. Lundbeck A/S
Overall Status: Active - Not Recruiting

Phase

4

Condition

Pain (Pediatric)

Headaches

Oral Facial Pain

Treatment

Eptinezumab

Clinical Study ID

NCT06701526
20668A
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • The participant has a diagnosis of migraine as defined by International HeadacheSociety (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) guidelines with a history of migraine of at least 12 months prior to theScreening Visit.

  • The participant has ≥8 migraine days per month for each month within the past 3months prior to the Screening Visit.

  • The participant has documented evidence of recent inadequate response to either oneanti-CGRP monoclonal antibody (mAb) (other than eptinezumab) or one gepant,indicated and used for migraine prevention.

Exclusion

Key Exclusion Criteria:

  • The participant has taken more than 10 tablets of ubrogepant or more than 8 tabletsof rimegepant per month as an acute migraine medication in the 1 month prior to thescreening visit and during the 4-week baseline period.

  • The participant has previously had an inadequate response to more than oneCGRP-targeting therapy (anti-CGRP mAb or gepants), indicated for migraineprevention.

  • The participant has a history of cancer, other than basal cell or stage 1 squamouscell 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 tonational/local guideline may be enrolled in the trial provided they have beenfollowed up, have been asymptomatic, and have had no treatment for prostate cancer.Participants under surveillance for a low and stable level of M-component areallowed.

  • The participant has previously been treated with eptinezumab.

Other protocol-defined inclusion and exclusion criteria apply.

Study Design

Total Participants: 164
Treatment Group(s): 1
Primary Treatment: Eptinezumab
Phase: 4
Study Start date:
December 18, 2024
Estimated Completion Date:
June 05, 2026

Connect with a study center

  • Barrow Neurological Institute

    Phoenix 5308655, Arizona 5551752 85013
    United States

    Site Not Available

  • Neuropain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • Sunwise Clinical Research, LLC.

    Oakland, California 94596
    United States

    Site Not Available

  • The Neuron Clinic

    San Marcos, California 92069
    United States

    Site Not Available

  • Neuropain Medical Center

    Fresno 5350937, California 5332921 93710
    United States

    Site Not Available

  • Sunwise Clinical Research, LLC.

    Oakland 5378538, California 5332921 94596
    United States

    Site Not Available

  • The Neuron Clinic

    San Marcos 5392368, California 5332921 92069
    United States

    Site Not Available

  • St. Joseph's Hospital and Medical Center - Barrow Neurological Institute

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Advanced Neurology of Colorado, LLC

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Research of the Rockies

    Parker, Colorado 80138
    United States

    Site Not Available

  • St. Joseph's Hospital and Medical Center - Barrow Neurological Institute

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Advanced Neurology of Colorado, LLC

    Longmont 5579276, Colorado 5417618 80501
    United States

    Site Not Available

  • Research of the Rockies

    Parker 5434006, Colorado 5417618 80138
    United States

    Site Not Available

  • Hasbani & Hasbani MDs

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • New England Institute for Neurology and Headache

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Hasbani & Hasbani MDs

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Site Not Available

  • New England Institute for Neurology and Headache

    Stamford 4843564, Connecticut 4831725 06905
    United States

    Site Not Available

  • Brainstorm Research

    Miami, Florida 33176
    United States

    Site Not Available

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Brainstorm Research

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Site Not Available

  • PANDA Neurology and Atlanta Headache Specialists

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • PANDA Neurology and Atlanta Headache Specialists

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Site Not Available

  • St Luke's Meridian Medical Center

    Meridian, Idaho 83642
    United States

    Site Not Available

  • St Luke's Meridian Medical Center

    Meridian 5600685, Idaho 5596512 83642
    United States

    Site Not Available

  • Chicago Headache Center & Research Institute

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Chicago Headache Center & Research Institute

    Chicago 4887398, Illinois 4896861 60657
    United States

    Site Not Available

  • Crescent City Headache and Neurology

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Crescent City Headache and Neurology

    New Orleans 4335045, Louisiana 4331987 70115
    United States

    Site Not Available

  • Neurology Center of New England P.C.

    Foxborough, Massachusetts 02035
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • MedVadis Research Corporation

    Watertown, Massachusetts 02472-3930
    United States

    Site Not Available

  • Mass Institute of Clinical Research

    Westborough, Massachusetts 01581
    United States

    Site Not Available

  • Neurology Center of New England P.C.

    Foxborough 4937222, Massachusetts 6254926 02035
    United States

    Site Not Available

  • MedVadis Research Corporation

    Watertown 4954611, Massachusetts 6254926 02472-3930
    United States

    Site Not Available

  • Mass Institute of Clinical Research

    Westborough 4955149, Massachusetts 6254926 01581
    United States

    Site Not Available

  • Memorial Healthcare

    Owosso, Michigan 48867
    United States

    Site Not Available

  • Memorial Healthcare

    Owosso 5004792, Michigan 5001836 48867
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12230
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc.

    Amherst, New York 14226
    United States

    Site Not Available

  • North Suffolk Neurology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Albany Medical College

    Albany 5106834, New York 5128638 12230
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc.

    Amherst 5107129, New York 5128638 14226
    United States

    Site Not Available

  • North Suffolk Neurology

    Commack 5113412, New York 5128638 11725
    United States

    Site Not Available

  • North Suffolk Neurology

    Port Jefferson Station 5132015, New York 5128638 11776
    United States

    Site Not Available

  • NeuroScience Research Center, LLC.

    Canton, Ohio 44718
    United States

    Site Not Available

  • Neuroscience Research Center, LLC

    Canton, Ohio 44178
    United States

    Site Not Available

  • C7 Research

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • NeuroScience Research Center, LLC.

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • C7 Research

    Cleveland 5150529, Ohio 5165418 44109
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh 5206379, Pennsylvania 6254927 15236
    United States

    Site Not Available

  • KCA Neurology, PLLC

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • KCA Neurology, PLLC

    Franklin 4623560, Tennessee 4662168 37067
    United States

    Site Not Available

  • Texas Neurology, PA

    Dallas, Texas 75206-5202
    United States

    Site Not Available

  • Texas Neurology, PA

    Dallas 4684888, Texas 4736286 75206-5202
    United States

    Site Not Available

  • Inova Health Care Services

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Inova Health Care Services

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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