A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Recruiting now Phase 3 NCT05164172
Run by H. Lundbeck A/S · for 6 to 17 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
🚫 You may not be able to join if…
- 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
- Yale University School of Medicine, New Haven, Connecticut, United States
- Ki Health Partners LLC DBA New England Institute for Clinical Research, Stamford, Connecticut, United States
- NW FL Clinical Research Group, LLC, Gulf Breeze, Florida, United States
- AGA Clinical Trials - Hialeah - 4980 W 10th Ave, Hialeah, Florida, United States
- Axcess Medical Research, Loxahatchee Groves, Florida, United States
- University of South Florida, Tampa, Florida, United States
- University of Kentucky, Lexington, Kentucky, United States
- University of Maryland School of Medicine, Baltimore, Maryland, United States
- Michigan Head Pain and Neurological Institute, Ann Arbor, Michigan, United States
- Michigan State University - Department of Neurology, East Lansing, Michigan, United States
- Helen Devos Childrens' Hospital - PIN, Grand Rapids, Michigan, United States
- Dent Neurosciences Research Center Incorporated, Amherst, New York, United States
+ 58 more sites.
Who to contact
Email contact via H. Lundbeck A/S · +45 36301311 · HQ_Medinfo@Lundbeck.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05164172.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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