Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (NCT04921384) | Clinical Trial Compass
CompletedPhase 3
Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine
China981 participantsStarted 2021-05-29
Plain-language summary
This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The participant has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit.
* The participant has a migraine onset at ≤50 years of age.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period:
* Migraine occurring on ≥8 days and headache occurring on ≥15 to ≤26 days.
* The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
* The participant is aged ≥18 (≥20 for Taiwan) and ≤75 years at the Screening Visit.
Exclusion Criteria:
* The participant has received any medication targeting the calcitonin gene-related peptide (CGRP) pathway as preventive treatment of migraine.
* The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
* The participant has a diagnosis of acute or active temporomandibular disorder.
* The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), oph…
What they're measuring
1
Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12)