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

RecruitingPhase 3Ages 6 Years - 17 YearsAllH. Lundbeck A/S
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Eptinezumab
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Where

64 sites
Yale School of Medicine - The Scirex Clinical Research Unit
New Haven, United States
New England Institute for Clinical Research (NEICR) - Stamford
Stamford, United States
Sarkis Clinical Trials - Gainsville
Gainesville, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, United States
AGA Clinical Trials
Hialeah, United States
Axcess Medical Research - Loxahatchee
Loxahatchee Groves, United States
University of South Florida (USF) - Tampa Campus
Tampa, United States
University of Kentucky (UK) - Markey Cancer Center
Lexington, United States

โ€ฆand 56 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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