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

RecruitingPhase 3

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Who can join

Ages 12 to 17 · All sexes

Full eligibility criteria
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 ≥15 to ≤26 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).

About the study

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.

What is being tested

Sponsor: H. Lundbeck A/S · Participants: 285 · Started: Jun 30, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04965675

Locations in the U.S.

ConnecticutKi Health Partners LLC DBA New England Institute for Clinical Research, Stamford
FloridaNW FL Clinical Research Group, LLC, Gulf Breeze
AGA Clinical Trials - Hialeah - 4980 W 10th Ave, Hialeah
University of South Florida - 13330 USF Laurel Dr, Tampa
KentuckyUniversity of Kentucky HealthCare (UKHC) Kentucky Clinic, Lexington
OhioCincinnati Children's Hospital Medical Center - PIN, Cincinnati
TexasRoad Runner Research Ltd, San Antonio
VirginiaChildren's Specialty Group (CSG), Norfolk
West VirginiaMarshall Health-Marshall University Medical Center, Huntington

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.