Chronic Migraine in Children study: Eptinezumab
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 (Vyepti)?
An investigational drug being studied for chronic migraine in children aged 12 to 17.
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 see if eptinezumab lowers the number of migraine days compared to a normal saline placebo.
- Who it's for
- It is looking for adolescents aged 12 to 17 who have chronic migraine.
- What's involved
- Participants will receive either eptinezumab or a saline injection and will track their migraine days during the study.
- Time commitment
- The study lasts several months and requires regular clinic visits and diary entries of migraine days.
- 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 is enrolling
- Stamford, Connecticut, United States
- Gulf Breeze, Florida, United States
- Hialeah, Florida, United States
- Tampa, Florida, United States
- Lexington, Kentucky, United States
- Cincinnati, Ohio, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
- Huntington, West Virginia, 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
- London, Ontario, Canada
- Genoa, Italy
- Pavia, Italy
- Rome, Italy
- Durango, Durango, Mexico
+ 22 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, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Stamford, Connecticut, United States; Gulf Breeze, Florida, United States; Hialeah, Florida, United States; Tampa, Florida, United States; Lexington, Kentucky, United States; Cincinnati, Ohio, United States and 36 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.