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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

🚫 You may not be able to join if…

• 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).

Where this trial is running

• Yale-New Haven Children's Hospital - PIN, New Haven, Connecticut, United States
• Ki Health Partners LLC DBA New England Institute for Clinical Research, Stamford, Connecticut, United States
• Children's National Medical Center, Washington D.C., District of Columbia, United States
• NW FL Clinical Research Group, LLC, Gulf Breeze, Florida, United States
• AGA Clinical Trials - Hialeah - 4980 W 10th Ave, Hialeah, Florida, United States
• Axcess Medical Research, Loxahatchee Groves, Florida, United States
• University of South Florida, Tampa, Florida, United States
• Clinical Integrative Research Center of Atlanta, Atlanta, Georgia, United States
• University of Kentucky HealthCare (UKHC) Kentucky Clinic, Lexington, Kentucky, United States
• University of Maryland, Baltimore, Maryland, United States
• Michigan Head Pain and Neurological Institute, Ann Arbor, Michigan, United States
• Michigan State University - Department of Neurology, East Lansing, Michigan, United States

+ 72 more sites.

Who to contact

Email contact via H. Lundbeck A/S · +45 36301311 · HQ_Medinfo@Lundbeck.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04965675.