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

June 11, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1128AAF
        • Completed
        • Expertia S.A- Mautalén Salud e Investigación
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7603
        • Completed
        • Hospital Privado de la Comunidad
    • Córdoba Province
      • Córdoba-Barrio Crisol, Córdoba Province, Argentina, X5014AKM
        • Recruiting
        • Hospital de Niños de la Santísima Trinidad
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Recruiting
        • Instituto Medico Río 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 Gesu
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l.
      • 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
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Recruiting
        • Azienda Ospedaliero Universitaria A Meyer (Duplicate)
      • 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.
    • State of Mexico
      • Ampl San Lucas Tepetlacalco, State of Mexico, 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 Nis
      • 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
    • Greater London
      • London, Greater London, 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
        • Completed
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lundbeck A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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