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

NCT06701526 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20668A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 28

Brief 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).

Conditions

Migraine

Keywords

Eptinezumab; CGRP-targeting therapies; anti-CGRP monoclonal antibodies (mAbs); Gepants

Outcome Measures

Primary Outcomes (1)

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

  Week 24

Secondary Outcomes (16)

• 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

Study Arms (1)

Eptinezumab

EXPERIMENTAL

Participants will receive eptinezumab at Baseline (Day 1) and Week 12

Drug: Eptinezumab

Interventions

Eptinezumab DRUG

Solution for infusion

Eptinezumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (28)

Neuropain Medical Center

Fresno, California, 93710, United States

Location

Sunwise Clinical Research, LLC.

Oakland, California, 94596, United States

Location

The Neuron Clinic

San Marcos, California, 92069, United States

Location

St. Joseph's Hospital and Medical Center - Barrow Neurological Institute

Aurora, Colorado, 80045, United States

Location

Advanced Neurology of Colorado, LLC

Longmont, Colorado, 80501, United States

Location

Research of the Rockies

Parker, Colorado, 80138, United States

Location

Hasbani & Hasbani MDs

New Haven, Connecticut, 06511, United States

Location

New England Institute for Neurology and Headache

Stamford, Connecticut, 06905, United States

Location

Brainstorm Research

Miami, Florida, 33176, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

PANDA Neurology and Atlanta Headache Specialists

Atlanta, Georgia, 30328, United States

Location

St Luke's Meridian Medical Center

Meridian, Idaho, 83642, United States

Location

Chicago Headache Center & Research Institute

Chicago, Illinois, 60657, United States

Location

Crescent City Headache and Neurology

New Orleans, Louisiana, 70115, United States

Location

Neurology Center of New England P.C.

Foxborough, Massachusetts, 02035, United States

Location

MedVadis Research Corporation

Watertown, Massachusetts, 02472-3930, United States

Location

Mass Institute of Clinical Research

Westborough, Massachusetts, 01581, United States

Location

Memorial Healthcare

Owosso, Michigan, 48867, United States

Location

Albany Medical College

Albany, New York, 12230, United States

Location

Dent Neurosciences Research Center, Inc.

Amherst, New York, 14226, United States

Location

North Suffolk Neurology

Port Jefferson Station, New York, 11776, United States

Location

NeuroScience Research Center, LLC.

Canton, Ohio, 44718, United States

Location

C7 Research

Cleveland, Ohio, 44109, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, 15236, United States

Location

KCA Neurology, PLLC

Franklin, Tennessee, 37067, United States

Location

Texas Neurology, PA

Dallas, Texas, 75206-5202, United States

Location

Inova Health Care Services

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  HQ_Medinfo@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (28)