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NCT05164172RecruitingPhase 3

A study with eptinezumab in children and adolescents (6 to 17 years) with chronic or episodic migraine (REJOIN)

Longterm, openlabel (doseblinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine

Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
276 (estimated)
First submitted
4 Mar 2024
Start date
7 Mar 2023
Lead sponsor
H. Lundbeck A/S
Diseases
Migraine
NCT number
NCT05164172
EU CT number
2022-502917-27-00
EudraCT number
2020-001649-38

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 276
  • 26 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patient 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.

Lab values

  • During lead-in Study19356A or Study19357A: - participant experienced anaphylactic 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.

Who the study is looking for

  • The patient must have completed Week 12 (completion) Visit of either Study 19356A (CM) or Study 19357A (EM) immediately prior to enrolment into this OLE study.

Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Hospital Alvaro Cunqueiro
Coordinator of this site? Confirm its status
VigoSpainRecruiting
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
Coordinator of this site? Confirm its status
CagliariItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Giannina Gaslini Institute For Scientific Hospitalization And Care
Coordinator of this site? Confirm its status
GenoaItalyRecruiting
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Neurological Institute Foundation Casimiro Mondino
Coordinator of this site? Confirm its status
PaviaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
Coordinator of this site? Confirm its status
PisaItalyRecruiting
Bambino Gesu Childrens Hospital
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Athleticomed Sp. z o.o.
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Coordinator of this site? Confirm its status
CracowPolandRecruiting
ETG Lublin Sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandRecruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Coordinator of this site? Confirm its status
OswiecimPolandRecruiting
ETG Neuroscience Sp. z o.o.
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WarsawPolandRecruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandRecruiting
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Coordinator of this site? Confirm its status
WrocławPolandRecruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
Coordinator of this site? Confirm its status
AlmadaPortugalRecruiting
CCAB Centro Clinico Academico Braga Associacao
Coordinator of this site? Confirm its status
BragaPortugalRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
Coordinator of this site? Confirm its status
CoimbraPortugalRecruiting
Hospital Cuf Descobertas S.A.
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LisbonPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
Unidade Local de Saude de Sao Joao E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.