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Clinical Trials in the UK / NCT04965675
Recruiting Phase 3

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

NCT04965675 · tracked via the Priya Life Science UK tracker
Sponsor
H. Lundbeck A/S
Phase
Phase 3
Started
2021-06-30
Last updated
2026-08-21

Condition(s) studied

Chronic Migraine in Children

Investigational drug(s) / intervention(s)

EptinezumabPlacebo

Eptinezumab: Eptinezumab will be administered per dose and schedule specified in the arm.

Placebo: Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (83)

FacilityCityRegionStatus
Yale-New Haven Children's Hospital - PIN New Haven Connecticut Completed
Ki Health Partners LLC DBA New England Institute for Clinical Research Stamford Connecticut Recruiting
Children's National Medical Center Washington D.C. District of Columbia Completed
Sarkis Clinical Trials - Gainesville Gainesville Florida Completed
NW FL Clinical Research Group, LLC Gulf Breeze Florida Recruiting
AGA Clinical Trials - Hialeah - 4980 W 10th Ave Hialeah Florida Recruiting
Axcess Medical Research - Loxahatchee Loxahatchee Groves Florida Completed
University of South Florida - 13330 USF Laurel Dr Tampa Florida Recruiting
Clinical Integrative Research Center of Atlanta (CIRCAtl) Atlanta Georgia Completed
University of Kentucky HealthCare (UKHC) Kentucky Clinic Lexington Kentucky Recruiting
University of Maryland-Marlene and Stewart Greenebaum Cancer Center Baltimore Maryland Completed
Michigan Head Pain and Neurological Institute Ann Arbor Michigan Completed
Corewell Health - Butterworth Hospital Grand Rapids Michigan Completed
Dent Neurosciences Research Center Incorporated Amherst New York Completed
North Suffolk Neurology-Commack Commack New York Completed
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte Charlotte North Carolina Completed
Cincinnati Children's Hospital Medical Center - PIN Cincinnati Ohio Recruiting
The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma Completed
Road Runner Research Ltd San Antonio Texas Recruiting
Children's Specialty Group (CSG) Norfolk Virginia Recruiting
Mary Bridge Children's Hospital - PIN Tacoma Washington Completed
Marshall Health-Marshall University Medical Center Huntington West Virginia Recruiting
Hospital Privado de La Comunidad Mar del Plata Buenos Aires Completed
Clínica Privada Independencia Munro Buenos Aires Completed
Sanatorio Allende S.A. Córdoba Cordoba, Argentina Completed
Hospital de Niños de La Santisima Trinidad Córdoba-Barrio Crisol Córdoba Province Recruiting
Instituto Médico Río Cuarto Río Cuarto Córdoba Province Recruiting
INECO Neurociencias Oroño Rosario Santa Fe Province Recruiting
Centro de Investigaciones Médicas Tucumán - PPDS San Miguel de Tucumán Tucumán Province Recruiting
Expertia S.A- Mautalén Salud e Investigación Buenos Aires Argentina Completed
Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA) Buenos Aires Argentina Completed
Hospital Britanico de Buenos Aires (HOB) Buenos Aires Argentina Completed
University of Alberta Hospital (UAH) Edmonton Alberta Completed
Medical Arts Health Research Group - Penticton - PPDS Penticton British Columbia Completed
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic Victoria British Columbia Recruiting
The Kids Clinic Ajax Ontario Recruiting
London Health Sciences Centre -800 Commissioners Rd E London Ontario Recruiting
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS Pavia Apulia Completed
IRCCS Ospedale Pediatrico Bambino Gesu Rome Lazio Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Lombardy Completed

+ 43 more sites — see the full list on the official registry below.

More H. Lundbeck A/S trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04965675 on ClinicalTrials.gov ↗ ← All trials in the UK