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

Last updated: January 14, 2025
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

4

Condition

Pain (Pediatric)

Headaches

Pain

Treatment

Eptinezumab

Clinical Study ID

NCT06701526
20668A
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • The participant has a diagnosis of migraine as defined by International HeadacheSociety (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) guidelines with a history of migraine of at least 12 months prior to theScreening Visit.

  • The participant has ≥8 migraine days per month for each month within the past 3months prior to the Screening Visit.

  • The participant has documented evidence of recent inadequate response to either oneanti-CGRP monoclonal antibody (mAb) (other than eptinezumab) or one gepant,indicated and used for migraine prevention.

Exclusion

Key Exclusion Criteria:

  • The participant has taken more than 10 tablets of ubrogepant or more than 8 tabletsof rimegepant per month as an acute migraine medication in the 1 month prior to thescreening visit and during the 4-week baseline period.

  • The participant has previously had an inadequate response to more than oneCGRP-targeting therapy (anti-CGRP mAb or gepants), indicated for migraineprevention.

  • The participant has a history of cancer, other than basal cell or stage 1 squamouscell 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 tonational/local guideline may be enrolled in the trial provided they have beenfollowed up, have been asymptomatic, and have had no treatment for prostate cancer.Participants under surveillance for a low and stable level of M-component areallowed.

  • The participant has previously been treated with eptinezumab.

Other protocol-defined inclusion and exclusion criteria apply.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Eptinezumab
Phase: 4
Study Start date:
December 18, 2024
Estimated Completion Date:
June 05, 2026

Connect with a study center

  • Neuroscience Research Center, LLC

    Canton, Ohio 44178
    United States

    Active - Recruiting

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