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

NCT ID: NCT04965675
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: H. Lundbeck A/S
Conditions: Chronic Migraine in Children

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 285 participants (Estimated).

What is being studied

Intervention: eptinezumab
Drug: Eptinezumab
Drug: Placebo

Who may be eligible

Ages: 12 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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).

Study locations

83 study locations are listed.

Recruiting site status is explicitly provided for 83 locations; 53 are listed as Recruiting.

Countries: Argentina, Canada, Italy, Mexico, Poland, Portugal, Serbia, Spain, Turkey (Türkiye), United Kingdom, United States

Buenos Aires, Argentina: 2
Córdoba Province, Argentina: 2
Cordoba, Argentina, Argentina: 1
Santa Fe Province, Argentina: 1
Tucumán Province, Argentina: 1
Alberta, Canada: 1
British Columbia, Canada: 2
Ontario, Canada: 2
Apulia, Italy: 1
Lazio, Italy: 1
Lombardy, Italy: 2
Sardinia, Italy: 1
Tuscany, Italy: 1
Jalisco, Mexico: 2
Michoacán, Mexico: 1
New Leon, Mexico: 1
Sinaloa, Mexico: 1
State of Mexico, Mexico: 1
Kuyavian-Pomerania, Poland: 1
Lesser Poland Voivodeship, Poland: 2
Lower Silesian Voivodeship, Poland: 1
Lublin Voivodeship, Poland: 1
Masovian Voivodeship, Poland: 2
Setúbal District, Portugal: 1
Madrid, Spain: 1
Pontevedra, Spain: 1
Valencia, Spain: 1
İzmir, Turkey (Türkiye): 1
Devon, United Kingdom: 1
Midlothian, United Kingdom: 1

Sample of listed locations

Hospital de Niños de La Santisima Trinidad — Córdoba-Barrio Crisol, Córdoba Province, X5014AKM, Argentina — Recruiting
Instituto Médico Río Cuarto — Río Cuarto, Córdoba Province, 5800, Argentina — Recruiting
INECO Neurociencias Oroño — Rosario, Santa Fe Province, S2000DTP, Argentina — Recruiting
Centro de Investigaciones Médicas Tucumán - PPDS — San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina — Recruiting
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic — Victoria, British Columbia, V8R 1J8, Canada — Recruiting
The Kids Clinic — Ajax, Ontario, L1Z 0M1, Canada — Recruiting
London Health Sciences Centre -800 Commissioners Rd E — London, Ontario, N6A 5W9, Canada — Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu — Rome, Lazio, 00165, Italy — Recruiting
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS — Pavia, Lombardy, 27100, Italy — Recruiting
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza — Cagliari, Sardinia, 09121, Italy — Recruiting
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS — Pavia, Tuscany, 27100, Italy — Recruiting
Istituto Giannina Gaslini IRCCS — Genoa, 16147, Italy — Recruiting
Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA) — Guadalajara, Jalisco, 44130, Mexico — Recruiting
Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia — Morelia, Michoacán, 58260, Mexico — Recruiting
ICARO Investigaciones en Medicina S.A. de C.V. — Chihuahua City, 31000, Mexico — Recruiting
Instituto de Investigationes Clinicas para la Salud A.C. — Durango, 34000, Mexico — Recruiting
Clinical Research Institute SC-Mexico — Tepetlacolco, 54055, Mexico — Recruiting
AthleticoMed Sp. z o.o. — Bydgoszcz, Kuyavian-Pomerania, 85-752, Poland — Recruiting
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa — Krakow, Lesser Poland Voivodeship, 30-363, Poland — Recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. — Oświęcim, Lesser Poland Voivodeship, 32-600, Poland — Recruiting
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak — Wroclaw, Lower Silesian Voivodeship, 52-210, Poland — Recruiting
ETG Lublin - PPDS — Lublin, Lublin Voivodeship, 20-412, Poland — Recruiting
ETG Neuroscience - PPDS — Warsaw, Masovian Voivodeship, 02-677, Poland — Recruiting
MTZ Clinical Research Powered by PRATIA - PPDS — Warsaw, Masovian Voivodeship, 02-172, Poland — Recruiting
Unidade Local de Saúde de Almada-Seixal, E. P. E (Hospital Garcia de Orta) — Almada, Setúbal District, 2805-267, Portugal — Recruiting

Study details

Start date: June 30, 2021
Primary completion date: September 5, 2026
Completion date: October 31, 2026
First posted: July 16, 2021

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT04965675
Registry last updated: August 21, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT04965675 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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