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MigrainePhase 3REJOINNCT05164172

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 64 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Migraine
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
64 sitesin 11 countries
Study dates
1 Dec 2021to 30 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

Who cannot join

  • 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.

Trial locations and contacts

64 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Email contact via H. Lundbeck A/S contact

+45 36301311

HQ_Medinfo@Lundbeck.com

64 sites in 11 countries

United States20 sites, 14 recruiting

  • Akron Children's Hospital

    Akron, Ohio, 44308-1062

    Recruiting

  • Dent Neurosciences Research Center

    Amherst, New York, 14226-1727

    Completed

  • Michigan Headache & Neurological Institute (MHNI)

    Ann Arbor, Michigan, 48104-5131

    Completed

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201-1509

    Recruiting

  • OnSite Clinical Solutions, LLC - Charlotte

    Charlotte, North Carolina, 28210-0106

    Completed

  • Cincinnati Children's Hospital Medical Center-Burnet Campus

    Cincinnati, Ohio, 45229-3026

    Recruiting

  • True North Neurology - Commack (North Suffolk Neurology)

    Commack, New York, 11725-2850

    Recruiting

  • Sarkis Clinical Trials - Gainsville

    Gainesville, Florida, 32607

    Completed

  • Corewell Health - Helen DeVos Children's Hospital (HDVCH) - Medical Genetics

    Grand Rapids, Michigan, 49503

    Completed

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561-4495

    Recruiting

  • AGA Clinical Trials

    Hialeah, Florida, 33012-3407

    Recruiting

  • Marshall Health-Marshall University Medical Center

    Huntington, West Virginia, 25701-3656

    Recruiting

  • University of Kentucky (UK) - Markey Cancer Center

    Lexington, Kentucky, 40536-0002

    Recruiting

  • Axcess Medical Research - Loxahatchee

    Loxahatchee Groves, Florida, 33470-9206

    Completed

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

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Yale School of Medicine - The Scirex Clinical Research Unit

    New Haven, Connecticut, 06519-1405

    Recruiting

  • Children's Specialty Group (CSG)

    Norfolk, Virginia, 23510

    Recruiting

  • Road Runner Research (RRR)

    San Antonio, Texas, 78249-3539

    Recruiting

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

    Stamford, Connecticut, 06905-1206

    Recruiting

  • University of South Florida (USF) - Tampa Campus

    Tampa, Florida, 33620

    Recruiting

Other trials in United States

Argentina6 sites, 4 recruiting

  • Mautalén Salud e Investigación

    Buenos Aires, Buenos Aires F.D., C1128AAF

    Completed

  • Hospital de Niños de la Santísima Trinidad

    Córdoba, Córdoba Province, X5014AKM

    Recruiting

  • Hospital Privado de Comunidad (HPC)

    Mar del Plata, Buenos Aires, B7602CBM

    Completed

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, 5800

    Recruiting

  • INECO Neurociencias Oroño

    Rosario, Santa Fe Province, S2000DTP

    Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL

    Recruiting

Other trials in Argentina

Italy6 sites, 4 recruiting

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

    Cagliari, South Sardinia, 09121

    Completed

  • Istituto Giannina Gaslini IRCCS

    Genoa, 16147

    Recruiting

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

    Milan, 20133

    Completed

  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

    Pavia, 27100

    Recruiting

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

    Pisa, 56126

    Recruiting

  • Ospedale Pediatrico Bambino Gesu - Gianicolo

    Rome, 00165

    Recruiting

Other trials in Italy

Poland5 sites, 5 recruiting

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363

    Recruiting

  • ETG Lublin

    Lublin, Lublin Voivodeship, 20-412

    Recruiting

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

    Oświęcim, Lesser Poland Voivodeship, 32-600

    Recruiting

  • MTZ Clinical Research Powered by PRATIA

    Warsaw, Masovian Voivodeship, 02-172

    Recruiting

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

    Warsaw, Masovian Voivodeship, 02-677

    Recruiting

Other trials in Poland

Portugal5 sites, 5 recruiting

  • Unidade Local de Saude de Almada-Seixal E.P.E. (ULSAS)

    Almada, Setúbal District, 2805-267

    Recruiting

  • Hospital de Braga

    Braga, 4710-367

    Recruiting

  • Hospital Pediátrico de Coimbra

    Coimbra, 3000-602

    Recruiting

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

    Porto, 4050

    Recruiting

  • Centro Hospitalar Universitario de Sao Joao (CHUSJ)

    Porto, 4200-319

    Recruiting

Other trials in Portugal

Serbia5 sites, 5 recruiting

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

    Belgrade, Beograd, 11000

    Recruiting

  • Clinical Center Kragujevac

    Kragujevac, Sumadijski Okrug, 34000

    Recruiting

  • University Clinical Center Nis

    Niš, 18 000

    Recruiting

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

    Novi Sad, Juznobacki Okrug, 21000

    Recruiting

  • Institute of Child and Youth Health Care of Vojvodina

    Novi Sad, Juznobacki Okrug, 21101

    Recruiting

Other trials in Serbia

Mexico4 sites, 4 recruiting

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

    Chihuahua City, 31000

    Recruiting

  • Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C)

    Durango, Durango, 34000

    Recruiting

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

    Guadalajara, Jalisco, 44130

    Recruiting

  • Clinical Research Institute SC-Mexico

    Tepetlacalco, State of Mexico, 54055

    Recruiting

Other trials in Mexico

United Kingdom4 sites, 4 recruiting

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

    Edinburgh, Eastern Scotland, EH16 4TJ

    Recruiting

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

    Glasgow, South Western Scotland, G51 4TF

    Recruiting

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk, NR31 6LA

    Recruiting

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London, WC1N 3JH

    Recruiting

Other trials in United Kingdom

Canada3 sites, 3 recruiting

  • Kids Clinic

    Ajax, Ontario, L1Z 0M1

    Recruiting

  • London Health Sciences Centre (LHSC)

    London, Ontario, N6A 5W9

    Recruiting

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

    Victoria, British Columbia, V8R 1J8

    Recruiting

Other trials in Canada

Spain3 sites, 3 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario Virgen del Rocio (HUVR)

    Seville, Seville, 41013

    Recruiting

Other trials in Spain

Turkey (Türkiye)3 sites, 3 recruiting

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

    Eskişehir, 26480

    Recruiting

  • İzmir Şehir Hastanesi

    Izmir, 35540

    Recruiting

  • Mersin Universitesi-Tip Fakultesi

    Mersin, 33343

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Read the detailed description

This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine [CM] study in adolescents) or 19357A (episodic migraine [EM] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.

Conditions
Migraine
Being tested
Eptinezumab
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EptinezumabDrug

    Also called Vyepti

    Concentrate for solution for infusion

Study groups in NCT05164172
Study groupRoleWhat they receive
Eptinezumab 300 mgExperimentalParticipants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Receives: Drug: Eptinezumab
Eptinezumab 100 mgExperimentalParticipants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
Receives: Drug: Eptinezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events

    Measured: Baseline up to Week 44

Secondary outcomes (4)

  1. Free Eptinezumab Plasma Concentration

    Measured: Baseline, Weeks 8, 12, 24, 36, and 44

  2. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])

    Measured: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44

  3. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

    Measured: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44

  4. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36

    Measured: Baseline, Weeks 12, 24, and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start1 Dec 2021
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164172
Sponsor's protocol ID
19379A
Other IDs
2022-502917-27-00
Acronym
REJOIN
Status last verified
Oct 2026
First submitted
7 Dec 2021
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 64 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Argentina, Italy, Poland, Portugal and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Email contact via H. Lundbeck A/S (+45 36301311, HQ_Medinfo@Lundbeck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (time frame: Baseline up to Week 44). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05164172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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