A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications
NCT ID: NCT06701526
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2024-12-18
2026-06-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eptinezumab
Participants will receive eptinezumab at Baseline (Day 1) and Week 12
Eptinezumab
Solution for infusion
Interventions
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Eptinezumab
Solution for infusion
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Neuropain Medical Center
Fresno, California, United States
Sunwise Clinical Research, LLC.
Oakland, California, United States
The Neuron Clinic
San Marcos, California, United States
Advanced Neurology of Colorado, LLC
Longmont, Colorado, United States
Research of the Rockies
Parker, Colorado, United States
Hasbani & Hasbani MDs
New Haven, Connecticut, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, United States
Brainstorm Research
Miami, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
PANDA Neurology and Atlanta Headache Specialists
Atlanta, Georgia, United States
St Luke's Meridian Medical Center
Meridian, Idaho, United States
Chicago Headache Center & Research Institute
Chicago, Illinois, United States
Crescent City Headache and Neurology
New Orleans, Louisiana, United States
Neurology Center of New England P.C.
Foxborough, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Mass Institute of Clinical Research
Westborough, Massachusetts, United States
Memorial Healthcare
Owosso, Michigan, United States
Albany Medical College
Albany, New York, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States
North Suffolk Neurology
Commack, New York, United States
NeuroScience Research Center, LLC.
Canton, Ohio, United States
C7 Research
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
KCA Neurology, PLLC
Franklin, Tennessee, United States
Texas Neurology, PA
Dallas, Texas, United States
Inova Health Care Services
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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20668A
Identifier Type: -
Identifier Source: org_study_id