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MigrainePhase 4NCT06701526

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

A Phase 4 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
21 sitesUnited States
Study dates
18 Dec 2024to 2 Sep 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Albany Medical College

    Albany, New York, 12208-3412

  • Dent Neurosciences Research Center

    Amherst, New York, 14226-1727

  • Michigan Headache & Neurological Institute (MHNI)

    Ann Arbor, Michigan, 48104-5131

  • Crescent City Headache and Neurology Center

    Chalmette, Louisiana, 70043-1668

  • Chicago Headache Center and Research Institute - Chicago

    Chicago, Illinois, 60657-9269

  • C7 Research

    Cleveland, Ohio, 44109

  • Neurology Center of New England, PC

    Foxborough, Massachusetts, 02035

  • KCA Neurology, PLLC

    Franklin, Tennessee, 37067

  • Headache Wellness Center

    Greensboro, North Carolina, 27405-6962

  • Baptist Health Center for Clinical Research (BHCCR)

    Little Rock, Arkansas, 72205-6355

  • Brainstorm Research, Inc.

    Miami, Florida, 33176

  • Hasbani Neurology - New Haven

    New Haven, Connecticut, 06511

  • Thomas Jefferson University Hospital - Breast Care Center

    Philadelphia, Pennsylvania, 19107-5563

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

    Phoenix, Arizona, 85013-4409

  • Mayo Clinic - Vascular Center - Arizona

    Phoenix, Arizona, 85054-4502

  • Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Road

    Pittsburgh, Pennsylvania, 15236-4604

  • North Suffolk Neurology - Port Jefferson Station

    Port Jefferson Station, New York, 11776

  • The Neuron Clinic - Escondido

    San Marcos, California, 92069

  • New England Institute for Neurology and Headache (NEINH) - Stamford

    Stamford, Connecticut, 06905

  • Sunwise Clinical Research, LLC

    Walnut Creek, California, 94549-4500

  • Mass Institute of Clinical Research

    Westborough, Massachusetts, 01581

Other trials in United States

About this study

Official title: 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).

Conditions
Migraine
Being tested
Eptinezumab
Keywords
Eptinezumab, CGRP-targeting therapies, anti-CGRP monoclonal antibodies (mAbs), Gepants
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EptinezumabDrug

    Solution for infusion

Study groups in NCT06701526
Study groupRoleWhat they receive
EptinezumabExperimentalParticipants will receive eptinezumab at Baseline (Day 1) and Week 12
Receives: Drug: Eptinezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Scale

    Measured: Week 24

Secondary outcomes (16)

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

    Measured: Weeks 1-12 and 13-24

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

    Measured: Weeks 1-12 and 13-24

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

    Measured: Weeks 1-12 and 13-24

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

    Measured: Weeks 1-12 and 13-24

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

    Measured: Week 12

  6. PGIC Score

    Measured: Weeks 12 and 24

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

    Measured: Weeks 12 and 24

  8. Goal Attainment Scaling (GAS) Score

    Measured: Weeks 12 and 24

  9. Number of Participants with GAS Score ≥50

    Measured: Weeks 12 and 24

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

    Measured: Weeks 12 and 24

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

    Measured: Weeks 12 and 24

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

    Measured: Weeks 12 and 24

  13. Brain Fog Score

    Measured: 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

    Measured: Weeks 12 and 24

  15. CGIC Score

    Measured: Weeks 12 and 24

  16. Number of Participants with Adverse Events (AEs)

    Measured: Up to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start18 Dec 2024
  3. Primary completion2 Sep 2026
  4. Study completion2 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06701526
Sponsor's protocol ID
20668A
Status last verified
Sep 2026
First submitted
20 Nov 2024
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06701526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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