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New hope for teens with chronic migraines?

NCT ID NCT04965675

Disease control Sponsor: H. Lundbeck A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests whether eptinezumab, given as an IV infusion, can reduce the number of migraine days in adolescents aged 12 to 17 who have chronic migraine (15 or more headache days per month). Participants will receive either the drug or a placebo (salt water) and track their headaches for 12 weeks. The goal is to see if the drug safely and effectively prevents migraines better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 285 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    53 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AGA Clinical Trials - Hialeah - 4980 W 10th Ave

    RECRUITING

    Hialeah, Florida, 33012, United States

  • AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza

    RECRUITING

    Cagliari, Sardinia, 09121, Italy

  • AthleticoMed Sp. z o.o.

    RECRUITING

    Bydgoszcz, Kuyavian-Pomerania, 85-752, Poland

  • Axcess Medical Research - Loxahatchee

    COMPLETED

    Loxahatchee Groves, Florida, 33470-9206, United States

  • Centro de Estudios Clinicos y Especialidades Medicas SC

    COMPLETED

    Monterrey, New Leon, 64620, Mexico

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia

    RECRUITING

    Morelia, Michoacán, 58260, Mexico

  • Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA)

    RECRUITING

    Guadalajara, Jalisco, 44130, Mexico

  • Centro de Investigaciones Médicas Tucumán - PPDS

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-363, Poland

  • Children and Youth Health Care Institute of Vojvodina

    RECRUITING

    Novi Sad, 21 000, Serbia

  • Children's National Medical Center

    COMPLETED

    Washington D.C., District of Columbia, 20010-2916, United States

  • Children's Specialty Group (CSG)

    RECRUITING

    Norfolk, Virginia, 23510-1021, United States

  • Childrens University Hospital

    RECRUITING

    Belgrade, 11000, Serbia

  • Cincinnati Children's Hospital Medical Center - PIN

    RECRUITING

    Cincinnati, Ohio, 45229-3026, United States

  • Clinical Center of Vojvodina - Clinic of Psychiatry

    RECRUITING

    Novi Sad, 21000, Serbia

  • Clinical Integrative Research Center of Atlanta (CIRCAtl)

    COMPLETED

    Atlanta, Georgia, 30328-5574, United States

  • Clinical Research Institute SC-Mexico

    RECRUITING

    Tepetlacolco, 54055, Mexico

  • Clínica Privada Independencia

    COMPLETED

    Munro, Buenos Aires, 1605, Argentina

  • Corewell Health - Butterworth Hospital

    COMPLETED

    Grand Rapids, Michigan, 49503-2560, United States

  • Dent Neurosciences Research Center Incorporated

    COMPLETED

    Amherst, New York, 14226-1727, United States

  • ETG Lublin - PPDS

    RECRUITING

    Lublin, Lublin Voivodeship, 20-412, Poland

  • ETG Neuroscience - PPDS

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-677, Poland

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Eskişehir, 26480, Turkey (Türkiye)

  • Expertia S.A- Mautalén Salud e Investigación

    COMPLETED

    Buenos Aires, C1128AAF, Argentina

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    COMPLETED

    Milan, Lombardy, 20133, Italy

  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

    COMPLETED

    Pavia, Apulia, 27100, Italy

  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

    RECRUITING

    Pavia, Tuscany, 27100, Italy

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Hospital Britanico de Buenos Aires (HOB)

    COMPLETED

    Buenos Aires, C1280AEB, Argentina

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA)

    COMPLETED

    Buenos Aires, C1181ACH, Argentina

  • Hospital Privado de La Comunidad

    COMPLETED

    Mar del Plata, Buenos Aires, B7602CBM, Argentina

  • Hospital Universitario Vall d'Hebron - PPDS

    COMPLETED

    Barcelona, Madrid, 08035, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    RECRUITING

    Seville, Pontevedra, 41013, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    RECRUITING

    Sevilla, Valencia, 41013, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    RECRUITING

    Seville, 41013, Spain

  • Hospital de Niños de La Santisima Trinidad

    RECRUITING

    Córdoba-Barrio Crisol, Córdoba Province, X5014AKM, Argentina

  • ICARO Investigaciones en Medicina S.A. de C.V.

    RECRUITING

    Chihuahua City, 31000, Mexico

  • INECO Neurociencias Oroño

    RECRUITING

    Rosario, Santa Fe Province, S2000DTP, Argentina

  • IRCCS Ospedale Pediatrico Bambino Gesu

    RECRUITING

    Rome, Lazio, 00165, Italy

  • Instituto Médico Río Cuarto

    RECRUITING

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Instituto de Investigationes Clinicas para la Salud A.C.

    RECRUITING

    Durango, 34000, Mexico

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    RECRUITING

    Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    RECRUITING

    Fatih/Istanbul, 34093, Turkey (Türkiye)

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    COMPLETED

    Fatih/Istanbul, 34096, Turkey (Türkiye)

  • Istituto Giannina Gaslini IRCCS

    RECRUITING

    Genoa, 16147, Italy

  • Izmir City Hospital

    RECRUITING

    Bayraklı, İzmir, 35540, Turkey (Türkiye)

  • James Paget University Hospitals NHS Foundation Trust

    RECRUITING

    Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

  • Ki Health Partners LLC DBA New England Institute for Clinical Research

    RECRUITING

    Stamford, Connecticut, 06905, United States

  • London Health Sciences Centre -800 Commissioners Rd E

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

  • MTZ Clinical Research Powered by PRATIA - PPDS

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • Marshall Health-Marshall University Medical Center

    RECRUITING

    Huntington, West Virginia, 25701-3656, United States

  • Mary Bridge Children's Hospital - PIN

    COMPLETED

    Tacoma, Washington, 98405-4048, United States

  • Medical Arts Health Research Group - Penticton - PPDS

    COMPLETED

    Penticton, British Columbia, V2A 5L5, Canada

  • Mersin University Medical Faculty

    RECRUITING

    Mersin, 33169, Turkey (Türkiye)

  • Michigan Head Pain and Neurological Institute

    COMPLETED

    Ann Arbor, Michigan, 48104-5131, United States

  • NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...

    RECRUITING

    Glasgow, North Lanarkshire, G51 4TF, United Kingdom

  • NW FL Clinical Research Group, LLC

    RECRUITING

    Gulf Breeze, Florida, 32561-4495, United States

  • Neurociencias Estudios Clinicos S.C.

    COMPLETED

    Culiacán, Sinaloa, 80050, Mexico

  • North Suffolk Neurology-Commack

    COMPLETED

    Commack, New York, 11725-2808, United States

  • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

    COMPLETED

    Charlotte, North Carolina, 28211-5027, United States

  • Road Runner Research Ltd

    RECRUITING

    San Antonio, Texas, 78249-3539, United States

  • Royal Devon and Exeter Hospital NHS Trust - PPDS

    COMPLETED

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Hospital for Children and Young People - PIN

    RECRUITING

    Edinburgh, Midlothian, EH16 4TJ, United Kingdom

  • Sanatorio Allende S.A.

    COMPLETED

    Córdoba, Cordoba, Argentina, X5000JHQ, Argentina

  • Sarkis Clinical Trials - Gainesville

    COMPLETED

    Gainesville, Florida, 32607, United States

  • The Kids Clinic

    RECRUITING

    Ajax, Ontario, L1Z 0M1, Canada

  • The University of Oklahoma Health Sciences Center

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

  • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

    RECRUITING

    Coimbra, 3000-602, Portugal

  • ULS de São João, EPE - Hospital de São João

    RECRUITING

    Porto, 4200-319, Portugal

  • Unidad de Investigación en Salud de Chihuahua S.C.

    COMPLETED

    Zapopan, Jalisco, 45150, Mexico

  • Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city

    COMPLETED

    México, State of Mexico, 14050, Mexico

  • Unidade Local de Saúde de Almada-Seixal, E. P. E (Hospital Garcia de Orta)

    RECRUITING

    Almada, Setúbal District, 2805-267, Portugal

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University of Alberta Hospital (UAH)

    COMPLETED

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Kentucky HealthCare (UKHC) Kentucky Clinic

    RECRUITING

    Lexington, Kentucky, 40508-1683, United States

  • University of Maryland-Marlene and Stewart Greenebaum Cancer Center

    COMPLETED

    Baltimore, Maryland, 21201-1595, United States

  • University of South Florida - 13330 USF Laurel Dr

    RECRUITING

    Tampa, Florida, 33620, United States

  • Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic

    RECRUITING

    Victoria, British Columbia, V8R 1J8, Canada

  • Yale-New Haven Children's Hospital - PIN

    COMPLETED

    New Haven, Connecticut, 06504-8901, United States