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Migraine drug vyepti tested in kids for long-term safety

NCT ID NCT05164172

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests the long-term safety of eptinezumab (Vyepti) in 600 children and teens aged 6 to 17 with chronic or episodic migraine. Participants must have completed a prior study. The main goal is to track side effects over time, with additional measures of drug levels and immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eptinezumab (Vyepti)
What this could lead to
If successful, this could confirm that eptinezumab is a safe long-term option to reduce migraine frequency in children and teens.
What could go wrong
This is an extension study focused on safety, not effectiveness. It may not show strong benefits, and side effects or lack of response could limit its use.

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 600 people

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

Started

Dec 2021

Expected to finish

Apr 2028

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: \- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study. Exclusion Criteria: * The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator. * During lead-in Study19356A or Study19357A: * participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator * the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later. * the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.

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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.

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

    61 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

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland

  • Axcess Medical Research

    COMPLETED

    Loxahatchee Groves, Florida, 33470-9272, United States

  • Azienda Ospedaliero Universitaria A Meyer (Duplicate)

    RECRUITING

    Florence, Tuscany, 50139, Italy

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

    RECRUITING

    Pisa, Tuscany, 56126, Italy

  • CHUVI - H.U. Alvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

  • Centro Clínico Académico, Braga - Hospital de Braga

    RECRUITING

    Braga, 4710-243, Portugal

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

    RECRUITING

    Guadalajara, Jalisco, 44700, 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 Specialty Group - 3 Commercial Place

    RECRUITING

    Norfolk, Virginia, 23510, United States

  • Children's Wisconsin - Milwaukee Campus - PIN

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Childrens Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308-1063, United States

  • Childrens University Hospital

    RECRUITING

    Belgrade, 11000, Serbia

  • Cincinnati Children's Hospital Medical Center - PIN

    RECRUITING

    Cincinnati, Ohio, 45229-3026, United States

  • Clinical Centre of Vojvodina

    RECRUITING

    Novi Sad, 21 000, Serbia

  • Clinical Research Institute SC-Mexico

    RECRUITING

    Ampl San Lucas Tepetlacalco, State of Mexico, 54055, Mexico

  • 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 Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    RECRUITING

    Pavia, 27100, Italy

  • Great Ormond Street Hospital - PPDS

    RECRUITING

    London, Greater London, WC1N 3JH, United Kingdom

  • Helen Devos Childrens' Hospital - PIN

    COMPLETED

    Grand Rapids, Michigan, 49503-2528, United States

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Privado de La Comunidad

    COMPLETED

    Mar del Plata, Buenos Aires, 7603, Argentina

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, 8025, 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 Istituto Giannina Gaslini

    RECRUITING

    Genoa, Liguria, 16147, Italy

  • 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

  • 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, 06905-1206, 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 University Medical Center

    RECRUITING

    Huntington, West Virginia, 25701-3656, United States

  • Mersin University Medical Faculty

    RECRUITING

    Mersin, 33169, Turkey (Türkiye)

  • Michigan Head Pain and Neurological Institute

    COMPLETED

    Ann Arbor, Michigan, 48104-5131, United States

  • Michigan State University - Department of Neurology

    COMPLETED

    East Lansing, Michigan, 48824-7015, United States

  • NW FL Clinical Research Group, LLC

    RECRUITING

    Gulf Breeze, Florida, 32561-4458, United States

  • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

    COMPLETED

    Charlotte, North Carolina, 28211-5027, United States

  • Ospedale San Raffaele S.r.l.

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • Queen Elizabeth University Hospital - PPDS

    RECRUITING

    Glasgow, G514TF, United Kingdom

  • Road Runner Research Ltd

    RECRUITING

    San Antonio, Texas, 78249-3539, United States

  • Royal Hospital for Children and Young People - PIN

    RECRUITING

    Edinburgh, Midlothian, EH16 4TJ, United Kingdom

  • The Kids Clinic

    RECRUITING

    Ajax, Ontario, L1Z 0M1, Canada

  • True North Neurology

    RECRUITING

    Commack, New York, 11725-2808, United States

  • ULS de Almada-Seixal, EPE - Hospital Garcia de Orta

    RECRUITING

    Almada, Setúbal District, 2805-267, Portugal

  • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

    RECRUITING

    Coimbra, 3000-602, Portugal

  • ULS de Santo António, EPE - Centro Materno Infantil Norte

    RECRUITING

    Porto Covo, Setúbal District, 4050-651, Portugal

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

    RECRUITING

    Porto, 4200-319, Portugal

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center Nis

    RECRUITING

    Niš, 18 000, Serbia

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536-7001, United States

  • University of Maryland School of Medicine

    RECRUITING

    Baltimore, Maryland, 21201-1544, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612-6601, United States

  • Vancouver Island Health Authority

    RECRUITING

    Victoria, British Columbia, V8R 1J8, Canada

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06511, United States

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