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
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Azienda Socio Sanitaria Locale N. 8 Di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Giannina Gaslini Institute For Scientific Hospitalization And Care Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Athleticomed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| ETG Lublin Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Recruiting |
| ETG Neuroscience Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak Coordinator of this site? Confirm its status | Wrocław | Poland | Recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Hospital Cuf Descobertas S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.