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New drug aims to cut migraine days in kids by half

NCT ID NCT05897320

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 5 times

Summary

This study tests whether eptinezumab, given through a vein, can safely reduce the number of migraine days in children and teens aged 6 to 17 with episodic migraine. Participants receive either the drug or a placebo, and researchers track monthly migraine days over 12 weeks. The goal is to find a preventive treatment that helps young people have fewer migraines.

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 315 people

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

Started

Jun 2023

Expected to finish

Aug 2027

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

6 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: * Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit. * During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit. * During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary. Exclusion Criteria: * History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min). * History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system. * Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded. * Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance. Other inclusion and exclusion criteria may apply.

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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.

Episodic migraine

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

    49 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

    RECRUITING

    Hialeah, Florida, 33012-3407, United States

  • Akron Children's Hospital

    RECRUITING

    Akron, Ohio, 44308-1062, United States

  • AthleticoMed Sp. z o.o.

    RECRUITING

    Bydgoszcz, Kuyavian-Pomerania, 85-752, Poland

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...

    RECRUITING

    Pisa, 56126, Italy

  • Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)

    RECRUITING

    Porto, 4050, Portugal

  • Centro Hospitalar Universitario de Sao Joao (CHUSJ)

    RECRUITING

    Porto, 4200-319, Portugal

  • Centro de Investigacion Clinica de Morelia, S.C.

    COMPLETED

    Morelia, Michoacán, 58070, Mexico

  • Centro de Investigaciones Medicas Tucuman

    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

  • Child Neurology Center (CNC) of Northwest Florida

    RECRUITING

    Gulf Breeze, Florida, 32561-4458, United States

  • Children's Specialty Group (CSG)

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Cincinnati Children's Hospital Medical Center-Burnet Campus

    RECRUITING

    Cincinnati, Ohio, 45229-3026, United States

  • Clinica Independencia

    COMPLETED

    Buenos Aires, 1605, Argentina

  • Clinical Center Kragujevac

    RECRUITING

    Kragujevac, Sumadijski Okrug, 34000, Serbia

  • Clinical Integrative Research Center of Atlanta (CIRCAtl)

    COMPLETED

    Atlanta, Georgia, 30328-5574, United States

  • Clinical Research Institute SC-Mexico

    RECRUITING

    Tepetlacolco, 54055, Mexico

  • Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

  • ETG Lublin

    RECRUITING

    Lublin, Lublin Voivodeship, 20-412, Poland

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)

    RECRUITING

    Eskişehir, 26480, Turkey (Türkiye)

  • European Trial group network Sp. z o.o - Neuroscience

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-677, Poland

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    COMPLETED

    Milan, 20133, Italy

  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

    RECRUITING

    Pavia, 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 CUF Descobertas, S.A.

    COMPLETED

    Lisbon, 1998-018, Portugal

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Pediátrico de Coimbra

    RECRUITING

    Coimbra, 3000-602, Portugal

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    RECRUITING

    Valencia, 46026, Spain

  • Hospital de Braga

    RECRUITING

    Braga, 4710-367, Portugal

  • Hospital de Niños de la Santísima Trinidad

    RECRUITING

    Córdoba, Córdoba Province, X5014AKM, Argentina

  • INECO Neurociencias Oroño

    RECRUITING

    Rosario, Santa Fe Province, S2000DTP, Argentina

  • Institute of Child and Youth Health Care of Vojvodina

    RECRUITING

    Novi Sad, Juznobacki Okrug, 21101, Serbia

  • Instituto Médico Río Cuarto

    RECRUITING

    Río Cuarto, Córdoba Province, 5800, Argentina

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

    RECRUITING

    Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

  • Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare

    RECRUITING

    Genoa, 16147, Italy

  • Izmir Şehir Hastanesi

    RECRUITING

    Izmir, 35540, Turkey (Türkiye)

  • James Paget University Hospitals NHS Foundation Trust

    RECRUITING

    Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

  • Kids Clinic

    RECRUITING

    Ajax, Ontario, L1Z 0M1, Canada

  • L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...

    RECRUITING

    Cagliari, South Sardinia, 09121, Italy

  • London Health Sciences Centre (LHSC)

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • MTZ Clinical Research Powered by PRATIA

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • Mautalen Salud e Investigacion

    COMPLETED

    Buenos Aires, C1128AAF, Argentina

  • Mersin Universitesi-Tip Fakultesi

    RECRUITING

    Mersin, 33343, Turkey (Türkiye)

  • Michigan Headache & Neurological Institute (MHNI)

    COMPLETED

    Ann Arbor, Michigan, 48104-5131, United States

  • NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...

    RECRUITING

    Glasgow, South Western Scotland, G51 4TF, United Kingdom

  • NHS Lothian - Royal Hospital for Children & Young People (RHCYP)

    RECRUITING

    Edinburgh, Eastern Scotland, EH16 4TJ, United Kingdom

  • New England Institute for Clinical Research (NEICR) - Stamford

    RECRUITING

    Stamford, Connecticut, 06905-1206, United States

  • OnSite Clinical Solutions, LLC - Charlotte

    COMPLETED

    Charlotte, North Carolina, 28210-0106, United States

  • Ospedale Pediatrico Bambino Gesu - Gianicolo

    RECRUITING

    Rome, 00165, Italy

  • Road Runner Research (RRR)

    RECRUITING

    San Antonio, Texas, 78249-3539, United States

  • The Medical Arts Health Research Group - Penticton

    COMPLETED

    Penticton, British Columbia, V2A 5C8, Canada

  • True North Neurology - Commack (North Suffolk Neurology)

    COMPLETED

    Commack, New York, 11725-2850, United States

  • UK HealthCare-Kentucky Clinic

    COMPLETED

    Lexington, Kentucky, 40536, United States

  • University Clinical Center Nis

    RECRUITING

    Niš, 18 000, Serbia

  • University of Maryland School of Medicine

    COMPLETED

    Baltimore, Maryland, 21201-1509, United States

  • University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic

    RECRUITING

    Novi Sad, Juznobacki Okrug, 21000, Serbia

  • University of South Florida (USF) - Tampa Campus

    RECRUITING

    Tampa, Florida, 33620, United States

  • Univerzitetska Decija Klinika (UDK) (University Children's Hospital)

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

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

    RECRUITING

    Victoria, British Columbia, V8R 1J8, Canada

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