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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lundbeck A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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