Ireland
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Recruiting Phase 3

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

NCT04965675 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2021-06-30
Last updated
2026-10-16

Condition(s) studied

Chronic Migraine in Children

Investigational drug(s) / intervention(s)

Eptinezumab →Placebo

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)

  • Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 — Baseline, Weeks 1-12

Trial sites (79)

FacilityCityRegionStatus
Yale-New Haven Children's Hospital New Haven Connecticut Completed
New England Institute for Clinical Research (NEICR) - Stamford Stamford Connecticut Recruiting
Children's National Hospital - Children's National Heart Center Washington D.C. District of Columbia Completed
Sarkis Clinical Trials - Gainsville Gainesville Florida Completed
NW FL Clinical Research Group, LLC Gulf Breeze Florida Recruiting
AGA Clinical Trials Hialeah Florida Recruiting
Axcess Medical Research - Loxahatchee Loxahatchee Groves Florida Completed
University of South Florida (USF) - Tampa Campus Tampa Florida Recruiting
Clinical Integrative Research Center of Atlanta (CIRCAtl) Atlanta Georgia Completed
UK HealthCare-Kentucky Clinic Lexington Kentucky Recruiting
University of Maryland-Marlene and Stewart Greenebaum Cancer Center Baltimore Maryland Completed
Michigan Headache & Neurological Institute (MHNI) Ann Arbor Michigan Completed
Corewell Health - Butterworth Hospital Grand Rapids Michigan Completed
Dent Neurosciences Research Center Amherst New York Completed
True North Neurology - Commack (North Suffolk Neurology) Commack New York Completed
OnSite Clinical Solutions, LLC - Charlotte Charlotte North Carolina Completed
Cincinnati Children's Hospital Medical Center-Burnet Campus Cincinnati Ohio Recruiting
University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center Oklahoma City Oklahoma Completed
Road Runner Research (RRR) San Antonio Texas Recruiting
Children's Specialty Group (CSG) Norfolk Virginia Recruiting
MultiCare Mary Bridge Children's Hospital and Health Center Tacoma Washington Completed
Marshall Health-Marshall University Medical Center Huntington West Virginia Recruiting
Hospital Privado de Comunidad (HPC) Mar del Plata Buenos Aires Completed
Mautalén Salud e Investigación Buenos Aires Buenos Aires F.D. Completed
Sanatorio Allende S.A. Córdoba Cordoba, Argentina Completed
Hospital de Niños de la Santísima Trinidad Córdoba Córdoba Province Recruiting
Instituto Médico Río Cuarto Río Cuarto Córdoba Province Recruiting
INECO Neurociencias Oroño Rosario Santa Fe Province Recruiting
Centro de Investigaciones Medicas Tucuman San Miguel de Tucumán Tucumán Province Recruiting
Clinica Independencia 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
The Medical Arts Health Research Group - Penticton Penticton British Columbia Completed
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic Victoria British Columbia Recruiting
Kids Clinic Ajax Ontario Recruiting
London Health Sciences Centre (LHSC) London Ontario Recruiting
L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... Cagliari South Sardinia Completed
Istituto Giannina Gaslini IRCCS Genoa Italy Recruiting
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Milan Italy Completed

+ 39 more sites — see the full list on the official registry below.

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