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Long-term safety of eptinezumab for children and adolescents with migraines

Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

Phase 3 Interventional H. Lundbeck A/S · NCT05164172

This study is testing the long-term safety of a migraine medication called eptinezumab in children and teens aged 6 to 17 who have chronic or episodic migraines.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorH. Lundbeck A/S Industry-sponsored
Drugs / interventionseptinezumab
Locations70 sites (New Haven, Connecticut and 69 other locations)
Trial IDNCT05164172 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety of eptinezumab in children and adolescents aged 6 to 17 who have chronic or episodic migraines. Participants who completed earlier studies on eptinezumab will be offered to continue in this open-label extension study. Those who received placebo in the previous studies will be randomly assigned to receive either 100 mg or 300 mg of eptinezumab. The study aims to gather data on the safety profile of the medication over an extended period.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6 to 17 who have completed a prior study on eptinezumab for migraines.

Not a fit: Patients who experienced severe adverse reactions to eptinezumab in previous studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective treatment option for managing migraines in children and adolescents.

How similar studies have performed: Other studies on eptinezumab have shown promising results, indicating potential for success in this extension study.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

New Haven, Connecticut and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.