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RecruitingPhase 3

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the long-term safety of eptinezumab in children and teens ages 6 to 17 with migraines that happen often or from time to time. It is for those who have just finished the Week 12 visit in one of two earlier studies.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Finished the Week 12 final visit in Study19356A (chronic migraine) or Study19357A (episodic migraine) right before joining this study.

Who can't join

  • Had a side effect or other safety concern linked to treatment in the earlier study that the study doctor thinks could make joining unsafe.
  • Had a severe or serious allergic reaction to the study drug infusion during the earlier study, as judged by the study doctor.
  • During the earlier study, had ALT or AST liver blood test levels more than 5 times the upper normal limit, confirmed by another test less than 2 weeks later.
  • During the earlier study, had ALT or AST liver blood test levels more than 3 times the upper normal limit, plus total bilirubin more than 2 times the upper normal limit. Bilirubin is a substance measured to check liver health.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (20)

CT

FL

KY

MD

MI

NC

NY

OH

TX

VA

WI

WV