RECRUITINGPhase 3INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
\- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Eptinezumab
Concentrate for solution for infusion
Locations (20)
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, 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
True North Neurology
Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina, United States
Childrens Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia, United States
Marshall University Medical Center
Huntington, West Virginia, United States
Children's Wisconsin - Milwaukee Campus - PIN
Milwaukee, Wisconsin, United States