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

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: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Eptinezumab

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93710
      • Neuropain Medical Center
    • Oakland, California, United States, 94596
      • Sunwise Clinical Research, LLC.
    • San Marcos, California, United States, 92069
      • The Neuron Clinic
  • Colorado
    • Aurora, Colorado, United States, 80045
      • St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
    • Longmont, Colorado, United States, 80501
      • Advanced Neurology of Colorado, LLC
    • Parker, Colorado, United States, 80138
      • Research of the Rockies
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Hasbani & Hasbani MDs
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Neurology and Headache
  • Florida
    • Miami, Florida, United States, 33176
      • Brainstorm Research
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute at Palm Beach Neurology
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • PANDA Neurology and Atlanta Headache Specialists
  • Idaho
    • Meridian, Idaho, United States, 83642
      • St Luke's Meridian Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center & Research Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Crescent City Headache and Neurology
  • Massachusetts
    • Foxborough, Massachusetts, United States, 02035
      • Neurology Center of New England P.C.
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
    • Westborough, Massachusetts, United States, 01581
      • Mass Institute of Clinical Research
  • Michigan
    • Owosso, Michigan, United States, 48867
      • Memorial Healthcare
  • New York
    • Albany, New York, United States, 12230
      • Albany Medical College
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center, Inc.
    • Port Jefferson Station, New York, United States, 11776
      • North Suffolk Neurology
  • Ohio
    • Canton, Ohio, United States, 44718
      • NeuroScience Research Center, LLC.
    • Cleveland, Ohio, United States, 44109
      • C7 Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc.
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • KCA Neurology, PLLC
  • Texas
    • Dallas, Texas, United States, 75206-5202
      • Texas Neurology, PA
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Health Care Services

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Monthly Migraine Days (MMDs)	Weeks 1-12 and 13-24
Change from Baseline in the Percentage of MMDs with Severe Pain Intensity	Weeks 1-12 and 13-24
Change from Baseline in Monthly Headache Days (MHDs)	Weeks 1-12 and 13-24
Change from Baseline in MMDs with Use of Acute Medication	Weeks 1-12 and 13-24
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale	Week 12
PGIC Score	Weeks 12 and 24
Change from Baseline in Migraine Disability Assessment (MIDAS) Scores	Weeks 12 and 24
Goal Attainment Scaling (GAS) Score	Weeks 12 and 24
Number of Participants with GAS Score ≥50	Weeks 12 and 24
Change from Baseline in Number of Good Days per Month	Weeks 12 and 24
Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score	Weeks 12 and 24
Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog	Weeks 12 and 24
Brain Fog Score	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	Weeks 12 and 24
CGIC Score	Weeks 12 and 24
Number of Participants with Adverse Events (AEs)	Up to Week 26

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, HQ_Medinfo@Lundbeck.com

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Eptinezumab; Gepants; CGRP-targeting therapies; anti-CGRP monoclonal antibodies (mAbs)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; eptinezumab
• Other Study ID 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