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A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

RecruitingPhase 3Ages 12 Years - 17 YearsAllH. Lundbeck A/S
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In plain words

What the trial is, and whether it could suit you

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit. * During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit. * During the 28-day screening period, the participant must have โ‰ฅ15 to โ‰ค26 headache days, of which at least 8 are migraine days as documented in the eDiary. Exclusion Criteria: * The participant has previously been randomised in this study and exposed to eptinezumab. * The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit. * The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit. * The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), 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), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).
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What it tests

  • Eptinezumab
  • Placebo
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Where

79 sites
Yale-New Haven Children's Hospital
New Haven, United States
New England Institute for Clinical Research (NEICR) - Stamford
Stamford, United States
Children's National Hospital - Children's National Heart Center
Washington D.C., United States
Sarkis Clinical Trials - Gainsville
Gainesville, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, United States
AGA Clinical Trials
Hialeah, United States
Axcess Medical Research - Loxahatchee
Loxahatchee Groves, United States
University of South Florida (USF) - Tampa Campus
Tampa, United States

โ€ฆand 71 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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