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
- Barcelona, Madrid, Sevilla, Valencia, and Vigo, SpainSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 6 to 17 with chronic or episodic migraine who finished a previous eptinezumab study. It checks the long-term safety of eptinezumab.
- Age
- 6 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Chronic or episodic migraine
- Earlier treatment
- Must have finished the Week 12 visit of study 19356A (chronic migraine) or study 19357A (episodic migraine) right before joining this study.
Main reasons for not taking part
- An adverse event or safety concern linked to the double-blind treatment in the earlier study that the investigator sees as a safety risk
- A severe or serious allergic reaction to the study drug infusion in the earlier study
- Liver test results (ALT or AST) above 5 times the upper limit of the reference range, confirmed by a repeat test less than 2 weeks later, in the earlier study
- ALT or AST above 3 times the upper limit together with total bilirubin above 2 times the upper limit in the earlier study
Read by machine on 9 November 2026.
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 Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
- Hospital Alvaro CunqueiroVigo, SpainTaking 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:.