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

April 13, 2026 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7603
        • Completed
        • Hospital Privado de La Comunidad
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1128AAF
        • Completed
        • Expertia S.A- Mautalen Salud e Investigación
    • Córdoba Province
      • Córdoba-Barrio Crisol, Córdoba Province, Argentina, X5014AKM
        • Recruiting
        • Hospital de Niños de La Santisima Trinidad
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Recruiting
        • Instituto Medico Rio Cuarto
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DTP
        • Recruiting
        • INECO Neurociencias Oroño
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Médicas Tucumán - PPDS
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Recruiting
        • Vancouver Island Health Authority
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • Recruiting
        • The Kids Clinic
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre -800 Commissioners Rd E
  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
    • Lazio
      • Rome, Lazio, Italy, 00165
        • Recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - INCIPIT - PIN
      • Milan, Lombardy, Italy, 20133
        • Completed
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Sardinia
      • Cagliari, Sardinia, Italy, 09121
        • Recruiting
        • AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Recruiting
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
      • Pisa, Tuscany, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • ICARO Investigaciones en Medicina, S.A de C.V
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigationes Clinicas para la Salud A.C.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44700
        • Recruiting
        • Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
    • México
      • Ampl San Lucas Tepetlacalco, México, Mexico, 54055
        • Recruiting
        • Clinical Research Institute SC-Mexico
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
        • Recruiting
        • AthleticoMed
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
      • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
        • Recruiting
        • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Recruiting
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-412
        • Recruiting
        • ETG Lublin - PPDS
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by PRATIA - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • Recruiting
        • ETG Neuroscience - PPDS
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Centro Clínico Académico, Braga - Hospital de Braga
      • Coimbra, Portugal, 3000-602
        • Recruiting
        • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
      • Porto, Portugal, 4200-319
        • Recruiting
        • ULS de São João, EPE - Hospital de São João
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Recruiting
        • ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
      • Porto Covo, Setúbal District, Portugal, 4050-651
        • Recruiting
        • ULS de Santo António, EPE - Centro Materno Infantil Norte
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Childrens University Hospital
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
      • Niš, Serbia, 18 000
        • Recruiting
        • University Clinical Center Niš
      • Novi Sad, Serbia, 21 000
        • Recruiting
        • Children and Youth Health Care Institute of Vojvodina
      • Novi Sad, Serbia, 21 000
        • Recruiting
        • Clinical Centre of Vojvodina
  • Spain
      • Barcelona, Spain, 8025
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio - PPDS
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • CHUVI - H.U. Alvaro Cunqueiro
  • Turkey (Türkiye)
      • Eskişehir, Turkey (Türkiye), 26480
        • Recruiting
        • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
      • Mersin, Turkey (Türkiye), 33169
        • Recruiting
        • Mersin University Medical Faculty
    • İzmir
      • Bayraklı, İzmir, Turkey (Türkiye), 35540
        • Recruiting
        • İzmir City Hospital
  • United Kingdom
      • Glasgow, United Kingdom, G514TF
        • Recruiting
        • Queen Elizabeth University Hospital - PPDS
    • London, City of
      • London, London, City of, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital - PPDS
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4TJ
        • Recruiting
        • Royal Hospital for Children and Young People - PIN
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
        • Recruiting
        • James Paget University Hospitals NHS Foundation Trust
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale University School of Medicine
      • Stamford, Connecticut, United States, 06905-1206
        • Recruiting
        • Ki Health Partners LLC DBA New England Institute for Clinical Research
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4458
        • Recruiting
        • NW FL Clinical Research Group, LLC
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • AGA Clinical Trials - Hialeah - 4980 W 10th Ave
      • Loxahatchee Groves, Florida, United States, 33470-9272
        • Completed
        • Axcess Medical Research
      • Tampa, Florida, United States, 33612-6601
        • Recruiting
        • University of South Florida
    • Kentucky
      • Lexington, Kentucky, United States, 40536-7001
        • Recruiting
        • University Of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21201-1544
        • Recruiting
        • University of Maryland School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Completed
        • Michigan Head Pain and Neurological Institute
      • East Lansing, Michigan, United States, 48824-7015
        • Completed
        • Michigan State University - Department of Neurology
      • Grand Rapids, Michigan, United States, 49503-2528
        • Recruiting
        • Helen Devos Childrens' Hospital - PIN
    • New York
      • Amherst, New York, United States, 14226-1727
        • Completed
        • Dent Neurosciences Research Center Incorporated
      • Commack, New York, United States, 11725-2808
        • Recruiting
        • True North Neurology
    • North Carolina
      • Charlotte, North Carolina, United States, 28211-5027
        • Completed
        • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
    • Ohio
      • Akron, Ohio, United States, 44308-1063
        • Recruiting
        • Childrens Hospital Medical Center of Akron
      • Cincinnati, Ohio, United States, 45229-3026
        • Recruiting
        • Cincinnati Children's Hospital Medical Center - PIN
    • Texas
      • San Antonio, Texas, United States, 78249-3539
        • Recruiting
        • Road Runner Research Ltd
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Recruiting
        • Children's Specialty Group - 3 Commercial Place
    • West Virginia
      • Huntington, West Virginia, United States, 25701-3656
        • Recruiting
        • Marshall University Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Wisconsin - Milwaukee Campus - PIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eptinezumab 300 mg
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Drug: Eptinezumab
Concentrate for solution for infusion
Other Names:
  • Vyepti
Experimental: Eptinezumab 100 mg
Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
Drug: Eptinezumab
Concentrate for solution for infusion
Other Names:
  • Vyepti

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment Emergent Adverse Events
Time Frame: Baseline up to Week 44
Baseline up to Week 44

Secondary Outcome Measures

Outcome Measure
Time Frame
Free Eptinezumab Plasma Concentration
Time Frame: Baseline, Weeks 8, 12, 24, 36, and 44
Baseline, Weeks 8, 12, 24, 36, and 44
Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36
Time Frame: Baseline, Weeks 12, 24, and 36
Baseline, Weeks 12, 24, and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19379A
  • 2022-502917-27-00 (Other Identifier: EU CTR No.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Eptinezumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe