A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
MigraineThe 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
6 to 17
Participation 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 Location
Vancouver Island Health Authority
Vancouver Island Health AuthorityVictoria, British Columbia
Canada
Contact Study Team
The Kids Clinic
The Kids ClinicAjax, Ontario
Canada
Contact Study Team
- Study Sponsored By
- H. Lundbeck A/S
- Participants Required
- More Information
- Study ID:
NCT05164172