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

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.

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Participation Requirements

  • 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 Authority
Victoria, British Columbia
Canada

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The Kids Clinic
The Kids Clinic
Ajax, Ontario
Canada

Contact Study Team

Study Sponsored By
H. Lundbeck A/S
Participants Required
More Information
Study ID: NCT05164172