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Ubrogepant for Pediatric Migraine
Study Summary
This trial is investigating the long-term safety and tolerability of ubrogepant in children and adolescents with a history of migraine.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can stop or switch any medication or diet that is not allowed in this study.You have previously completed a specific study or you were not able to participate in the study because you responded to a placebo.
- Group 1: Ubrogepant Dose A (12 to 17 Years Old)
- Group 2: Ubrogepant Dose B (6 to 11 Years Old)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research project only available to people under the age of 35?
"Children as young as 6 and no older than 17 years of age may participate in this clinical trial, according to the inclusion criteria."
How many patients are currently participating in this experiment?
"According to the information available on clinicaltrials.gov, this trial is currently ongoing and looking for new participants. The trial was first posted on January 14th, 2022 and was last updated on November 7th, 2022. The study is looking for 1200 patients to be enrolled at 100 different locations."
Who can join this research project?
"This study will allow up to 1200 adolescents aged 6-17 that suffer from migraines to participate. The most crucial part is that these patients must have a history of compliance with study procedures and lack any medical conditions which could make this study unsafe."
When will Ubrogepant be cleared for public consumption by the FDA?
"Ubrogepant is classified as a Phase 3 drug, meaning that while there is some data supporting efficacy, there is more data supporting safety. As such, our team has given it a score of 3."
Are there any other examples of Ubrogepant being used in a medical setting?
"Ubrogepant was first studied in 2022 at Ponce Medical School Foundation. As of now, there have been 8 completed studies with 2 more active trials. A large portion of these studies are being conducted in Cincinnati, Ohio."
Is this research project ongoing in more than one US city?
"The trial is being conducted by Patient Priority Clinical Sites, LLC /ID# 240051 in Cincinnati, Ohio, Coastal Georgia Child Neurology /ID# 240845 in Brunswick, Georgia, Coastal Pediatric Research - West Ashley A /ID# 240708 in Charleston, South carolina, and 100 other research centres."
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