Phase
Condition
Pain (Pediatric)
Headaches
Pain
Treatment
Eptinezumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Neuroscience Research Center, LLC
Canton, Ohio 44178
United StatesActive - Recruiting
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