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
- Akron, Amherst, Ann Arbor, Baltimore, Charlotte, Cincinnati, Commack, Gainesville, Grand Rapids, Gulf Breeze, Hialeah, Huntington, Lexington, Loxahatchee Groves, Milwaukee, New Haven, Norfolk, San Antonio, Stamford, and Tampa, United StatesSee the 20 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 United States
- Akron Children's HospitalAkron, United StatesTaking people
- Dent Neurosciences Research CenterAmherst, United StatesNo longer taking part
- Michigan Headache & Neurological Institute (MHNI)Ann Arbor, United StatesNo longer taking part
- University of Maryland School of MedicineBaltimore, United StatesTaking people
- OnSite Clinical Solutions, LLC - CharlotteCharlotte, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical Center-Burnet CampusCincinnati, United StatesTaking people
- True North Neurology - Commack (North Suffolk Neurology)Commack, United StatesTaking people
- Sarkis Clinical Trials - GainsvilleGainesville, United StatesNo longer taking part
- Corewell Health - Helen DeVos Children's Hospital (HDVCH) - Medical GeneticsGrand Rapids, United StatesNo longer taking part
- NW FL Clinical Research Group, LLCGulf Breeze, United StatesTaking people
- AGA Clinical TrialsHialeah, United StatesTaking people
- Marshall Health-Marshall University Medical CenterHuntington, United StatesTaking people
- University of Kentucky (UK) - Markey Cancer CenterLexington, United StatesTaking people
- Axcess Medical Research - LoxahatcheeLoxahatchee Groves, United StatesNo longer taking part
- Children's Wisconsin (Children's Hospital of Wisconsin)-Main CampusMilwaukee, United StatesTaking people
- Yale School of Medicine - The Scirex Clinical Research UnitNew Haven, United StatesTaking people
- Children's Specialty Group (CSG)Norfolk, United StatesTaking people
- Road Runner Research (RRR)San Antonio, United StatesTaking people
- New England Institute for Clinical Research (NEICR) - StamfordStamford, United StatesTaking people
- University of South Florida (USF) - Tampa CampusTampa, United StatesTaking 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:.