Long-term study of eptinezumab for migraine in children and teens
Tests eptinezumab's long-term safety in children and teens with migraine.
Plain-language title generated from the registry record
Registry title: A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Key facts
- Where
- Cagliari, Florence, Genoa, Milan, Pavia, Pisa, and Rome, ItalySee the 8 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT05164172, who can take part
Where in Italy
- Azienda Socio Sanitaria Locale N. 8 Di CagliariCagliari, ItalyTaking people
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
- Giannina Gaslini Institute For Scientific Hospitalization And CareGenoa, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Neurological Institute Foundation Casimiro MondinoPavia, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Bambino Gesu Childrens HospitalRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- H. Lundbeck A/S
- Trial code
- NCT05164172EU 2022-502917-27-00
- Record updated
- 14 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
Exclusion: 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; 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; During lead-in Study19356A or Study19357A:.