BridgeMD
New treatment option for Migraine
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?
Eptinezumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for migraine.
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 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.
- 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...
- During lead-in Study19356A or Study19357A:
- 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's taking place
- New Haven, Connecticut, United States
- Stamford, Connecticut, United States
- Gulf Breeze, Florida, United States
- Hialeah, Florida, United States
- Loxahatchee Groves, Florida, United States
- Tampa, Florida, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- East Lansing, Michigan, United States
- Grand Rapids, Michigan, United States
- Amherst, New York, United States
- Commack, New York, United States
- Charlotte, North Carolina, 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
+ 47 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 - 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?
Study sites include New Haven, Connecticut, United States; Stamford, Connecticut, United States; Gulf Breeze, Florida, United States; Hialeah, Florida, United States; Loxahatchee Groves, Florida, United States; Tampa, Florida, United States and 61 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.