Long-term safety of eptinezumab for children and adolescents with migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the long-term safety of eptinezumab in children and adolescents aged 6 to 17 who have chronic or episodic migraines. Participants who completed earlier studies on eptinezumab will be offered to continue in this open-label extension study. Those who received placebo in the previous studies will be randomly assigned to receive either 100 mg or 300 mg of eptinezumab. The study aims to gather data on the safety profile of the medication over an extended period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale School of Medicine - The Scirex Clinical Research Unit
  New Haven, Connecticut, United States Recruiting
• New England Institute for Clinical Research (NEICR) - Stamford
  Stamford, Connecticut, United States Recruiting
• NW FL Clinical Research Group, LLC
  Gulf Breeze, Florida, United States Recruiting
• AGA Clinical Trials
  Hialeah, Florida, United States Recruiting
• University of South Florida (USF) - Tampa Campus
  Tampa, Florida, United States Recruiting
• University of Kentucky (UK) - Markey Cancer Center
  Lexington, Kentucky, United States Recruiting

+14 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S
• Email: HQ_Medinfo@Lundbeck.com
• Phone: +45 36301311

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.