Eptinezumab in Adults With Migraine and Medication Overuse Headache (NCT04772742) | Clinical Trial Compass
CompletedPhase 3
Eptinezumab in Adults With Migraine and Medication Overuse Headache
China193 participantsStarted 2021-02-17
Plain-language summary
This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache
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 patient has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 guidelines confirmed at the Screening Visit with a history of migraine onset of at least 12 months prior to the Screening Visit.
* The patient has ≥8 migraine days per month for each month on average within the past 3 months prior to the Screening Visit.
* The patient has a diagnosis of medication overuse headache (MOH) as defined by IHS ICHD-3 guidelines.
* The patient has headache on ≥15 days/month for each month within the past 3 months prior to the Screening Visit.
* The patient has regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache, for \>3 months.
* The patient has ≥15 to ≤26 headache days, of which ≥8 days were assessed as migraine days during the Screening Period, based on prospectively collected information in the eDiary.
* The patient overuses drugs that can be taken for acute and/or symptomatic treatment of headache during the Screening Period, based on prospectively collected information in the eDiary.
* The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days of the Screening Period.
* The patient has had an onset of migraine at \<50 years of age
Exclusion Criteria:
* The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pa…
What they're measuring
1
Change from baseline in the number of monthly migraine days (MMDs)