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New treatment option for Chronic Migraine in Children
Official title A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
ClinicalTrials.gov ID: NCT04965675
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 chronic migraine in children.
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
- To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic 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 12 to 17
You may be able to join if
- The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3)...
- During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the...
- During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the...
You likely can't join if
- The participant has previously been assigned by chance in this study and exposed to eptinezumab.
- The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
- The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP...
- The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Stamford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Gulf Breeze, Florida, United States
- Hialeah, Florida, United States
- Loxahatchee Groves, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, 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
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
+ 59 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, 12 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; Washington D.C., District of Columbia, United States; Gulf Breeze, Florida, United States; Hialeah, Florida, United States; Loxahatchee Groves, Florida, United States and 73 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.