Migraine study: Eptinezumab
Official title A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
ClinicalTrials.gov ID: NCT05164172
What this study is testing
What is Eptinezumab?
An investigational intravenous infusion being studied as a potential treatment for migraine in children and adolescents. is designed to bind to calcitonin gene‑related peptide (CGRP) and prevent it from activating its receptor.
Also referred to as Vyepti.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how safe eptinezumab is when used over a long period in young people with migraine.
- Who it's for
- Children and adolescents ages 6 to 17 who have chronic or episodic migraine.
- What's involved
- Participants will receive eptinezumab injections and attend regular visits for safety checks and tests.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- \- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into...
You likely can't join if
- The participant has an adverse event or other safety concerns that are deemed related to blinded treatment received in the lead-in study and is...
- participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product...
- the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Stamford, Connecticut, United States
- Gulf Breeze, Florida, United States
- Hialeah, Florida, United States
- Tampa, Florida, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Commack, New York, United States
- Akron, Ohio, United States
- Cincinnati, Ohio, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
- Huntington, West Virginia, United States
- Milwaukee, Wisconsin, United States
- Córdoba, Córdoba Province, Argentina
- Río Cuarto, Córdoba Province, Argentina
- Rosario, Santa Fe Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Victoria, British Columbia, Canada
- Ajax, Ontario, Canada
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Stamford, Connecticut, United States; Gulf Breeze, Florida, United States; Hialeah, Florida, United States; Tampa, Florida, United States; Lexington, Kentucky, United States and 45 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.