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NCT Number: NCT06701526

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neuropain Medical Center, Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eptinezumab

Drug

Solution for infusion

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline in Monthly Migraine Days (MMDs)

    Time frame: Weeks 1-12 and 13-24

  2. Change from Baseline in the Percentage of MMDs with Severe Pain Intensity

    Time frame: Weeks 1-12 and 13-24

  3. Change from Baseline in Monthly Headache Days (MHDs)

    Time frame: Weeks 1-12 and 13-24

  4. Change from Baseline in MMDs with Use of Acute Medication

    Time frame: Weeks 1-12 and 13-24

  5. Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale

    Time frame: Week 12

  6. PGIC Score

    Time frame: Weeks 12 and 24

  7. Change from Baseline in Migraine Disability Assessment (MIDAS) Scores

    Time frame: Weeks 12 and 24

  8. Goal Attainment Scaling (GAS) Score

    Time frame: Weeks 12 and 24

  9. Number of Participants with GAS Score ≥50

    Time frame: Weeks 12 and 24

  10. Change from Baseline in Number of Good Days per Month

    Time frame: Weeks 12 and 24

  11. Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score

    Time frame: Weeks 12 and 24

  12. Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog

    Time frame: Weeks 12 and 24

  13. Brain Fog Score

    Time frame: Weeks 12 and 24

  14. 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

  15. CGIC Score

    Time frame: Weeks 12 and 24

  16. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Week 26

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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