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NCT06701526 | NOT YET RECRUITING | Migraine

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

H. Lundbeck A/S

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).

Condition or disease

Migraine

Intervention/treatment

Eptinezumab

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies
Actual Study Start Date : 2024-12-05
Estimated Primary Completion Date : 2026-06-05
Estimated Study Completion Date : 2026-06-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications

Location Details

NCT06701526

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Ohio

Neuroscience Research Center, LLC

Canton, Ohio, United States, 44178