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CompletedNCT06701526Updated Sep 9, 2026

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

A Phase 4 interventional study of Eptinezumab in Migraine, sponsored by H. Lundbeck A/S. Completed at 21 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by H. Lundbeck A/S · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
164
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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).

02

Conditions studied

  • Migraine

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Keywords

  • Eptinezumab
  • CGRP-targeting therapies
  • anti-CGRP monoclonal antibodies (mAbs)
  • Gepants
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 164 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    Eptinezumab

    Participants will receive eptinezumab at Baseline (Day 1) and Week 12

    Drug: Eptinezumab

Interventions

  • DrugEptinezumab

    Solution for infusion

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline in Monthly Migraine Days (MMDs)

    Time frame: Weeks 1-12 and 13-24

  2. Change from Baseline in the Percentage of MMDs with Severe Pain Intensity

    Time frame: Weeks 1-12 and 13-24

  3. Change from Baseline in Monthly Headache Days (MHDs)

    Time frame: Weeks 1-12 and 13-24

  4. Change from Baseline in MMDs with Use of Acute Medication

    Time frame: Weeks 1-12 and 13-24

  5. Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale

    Time frame: Week 12

  6. PGIC Score

    Time frame: Weeks 12 and 24

  7. Change from Baseline in Migraine Disability Assessment (MIDAS) Scores

    Time frame: Weeks 12 and 24

  8. Goal Attainment Scaling (GAS) Score

    Time frame: Weeks 12 and 24

  9. Number of Participants with GAS Score ≥50

    Time frame: Weeks 12 and 24

  10. Change from Baseline in Number of Good Days per Month

    Time frame: Weeks 12 and 24

  11. Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score

    Time frame: Weeks 12 and 24

  12. Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog

    Time frame: Weeks 12 and 24

  13. Brain Fog Score

    Time frame: Weeks 12 and 24

  14. 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

  15. CGIC Score

    Time frame: Weeks 12 and 24

  16. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Week 26

07

Study locations

21 sites
  • St. Joseph's Hospital and Medical Center-Barrow Neurological Institute - Barrow Brain Tumor Resea...
    Phoenix, Arizona 85013-4409, United States
  • Mayo Clinic - Vascular Center - Arizona
    Phoenix, Arizona 85054-4502, United States
  • Baptist Health Center for Clinical Research (BHCCR)
    Little Rock, Arkansas 72205-6355, United States
  • The Neuron Clinic - Escondido
    San Marcos, California 92069, United States
  • Sunwise Clinical Research, LLC
    Walnut Creek, California 94549-4500, United States
  • Hasbani Neurology - New Haven
    New Haven, Connecticut 06511, United States
  • New England Institute for Neurology and Headache (NEINH) - Stamford
    Stamford, Connecticut 06905, United States
  • Brainstorm Research, Inc.
    Miami, Florida 33176, United States
  • Chicago Headache Center and Research Institute - Chicago
    Chicago, Illinois 60657-9269, United States
  • Crescent City Headache and Neurology Center
    Chalmette, Louisiana 70043-1668, United States
  • Neurology Center of New England, PC
    Foxborough, Massachusetts 02035, United States
  • Mass Institute of Clinical Research
    Westborough, Massachusetts 01581, United States
  • Michigan Headache & Neurological Institute (MHNI)
    Ann Arbor, Michigan 48104-5131, United States
  • Albany Medical College
    Albany, New York 12208-3412, United States
  • Dent Neurosciences Research Center
    Amherst, New York 14226-1727, United States
  • North Suffolk Neurology - Port Jefferson Station
    Port Jefferson Station, New York 11776, United States
  • Headache Wellness Center
    Greensboro, North Carolina 27405-6962, United States
  • C7 Research
    Cleveland, Ohio 44109, United States
  • Thomas Jefferson University Hospital - Breast Care Center
    Philadelphia, Pennsylvania 19107-5563, United States
  • Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Road
    Pittsburgh, Pennsylvania 15236-4604, United States
  • KCA Neurology, PLLC
    Franklin, Tennessee 37067, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06701526
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Nov 22, 2024
Start date
Dec 18, 2024
Primary completion
Sep 2, 2026
Completion
Sep 2, 2026
Last update
Sep 9, 2026

Study contacts

Email contact via H. Lundbeck A/S
study director · HQ_Medinfo@Lundbeck.com

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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