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.
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
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 group | Role | What they receive |
|---|---|---|
| Eptinezumab | Experimental | Participants 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.
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)
Change from Baseline in Monthly Migraine Days (MMDs)
Measured: Weeks 1-12 and 13-24
Change from Baseline in the Percentage of MMDs with Severe Pain Intensity
Measured: Weeks 1-12 and 13-24
Change from Baseline in Monthly Headache Days (MHDs)
Measured: Weeks 1-12 and 13-24
Change from Baseline in MMDs with Use of Acute Medication
Measured: Weeks 1-12 and 13-24
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale
Measured: Week 12
PGIC Score
Measured: Weeks 12 and 24
Change from Baseline in Migraine Disability Assessment (MIDAS) Scores
Measured: Weeks 12 and 24
Goal Attainment Scaling (GAS) Score
Measured: Weeks 12 and 24
Number of Participants with GAS Score ≥50
Measured: Weeks 12 and 24
Change from Baseline in Number of Good Days per Month
Measured: Weeks 12 and 24
Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score
Measured: Weeks 12 and 24
Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog
Measured: Weeks 12 and 24
Brain Fog Score
Measured: 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
Measured: Weeks 12 and 24
CGIC Score
Measured: Weeks 12 and 24
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.
- First posted22 Nov 2024
- Study start18 Dec 2024
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, HQ_Medinfo@Lundbeck.com
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies
- ClinicalTrials.gov ID
- NCT06701526
- Acronym / sponsor ID
- 20668A
- Conditions
- Migraine
- Keywords
- Eptinezumab, CGRP-targeting therapies, anti-CGRP monoclonal antibodies (mAbs), Gepants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eptinezumab | Experimental | Drug: EptinezumabParticipants will receive eptinezumab at Baseline (Day 1) and Week 12 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EptinezumabSolution for infusion | Drug | Eptinezumab |
Primary outcome
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
16 secondary outcomes
Change from Baseline in Monthly Migraine Days (MMDs)
Time frame: 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
Change from Baseline in Monthly Headache Days (MHDs)
Time frame: Weeks 1-12 and 13-24
Change from Baseline in MMDs with Use of Acute Medication
Time frame: 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
PGIC Score
Time frame: Weeks 12 and 24
Change from Baseline in Migraine Disability Assessment (MIDAS) Scores
Time frame: Weeks 12 and 24
Goal Attainment Scaling (GAS) Score
Time frame: Weeks 12 and 24
Number of Participants with GAS Score ≥50
Time frame: Weeks 12 and 24
Change from Baseline in Number of Good Days per Month
Time frame: Weeks 12 and 24
Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score
Time frame: 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
Brain Fog Score
Time frame: 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
CGIC Score
Time frame: Weeks 12 and 24
Number of Participants with Adverse Events (AEs)
Time frame: Up to Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
HQ_Medinfo@Lundbeck.com
21 sites in 1 country: see every site and its status.
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?
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.