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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Ubrogepant for Pediatric Migraine

Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 54 weeks
Awards & highlights

Study Summary

This trial is investigating the long-term safety and tolerability of ubrogepant in children and adolescents with a history of migraine.

Who is the study for?
This trial is for kids aged 6-17 with migraines who were in a previous study or got placebo. They must have followed the earlier study's rules and not had bad side effects. Kids can't join if they take certain meds, like barbiturates, eat grapefruit, have serious health issues, are at risk of self-harm, or might not stick to the study plan.Check my eligibility
What is being tested?
The trial tests Ubrogepant tablets for treating migraines in kids. It checks how safe and tolerable it is over up to 54 weeks. Participants can treat up to 8 migraines a month with an option for a second dose after two hours or other rescue meds.See study design
What are the potential side effects?
Possible side effects aren't detailed here but will be monitored through medical exams, blood tests, tracking adverse events (like unexpected symptoms), and questionnaires about how participants feel during treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 54 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
Change from baseline in Tanner staging score
Percentage of Participants with Adverse Events (AEs)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ubrogepant Dose B (6 to 11 Years Old)Experimental Treatment1 Intervention
Participants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of any intensity.
Group II: Ubrogepant Dose A (12 to 17 Years Old)Experimental Treatment1 Intervention
Participants will receive oral tablets of ubrogepant Dose A for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of any intensity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ubrogepant
2016
Completed Phase 4
~4990

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
274,593 Total Patients Enrolled
9 Trials studying Migraine
3,905 Patients Enrolled for Migraine
AbbVieLead Sponsor
946 Previous Clinical Trials
495,272 Total Patients Enrolled
9 Trials studying Migraine
5,695 Patients Enrolled for Migraine
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
77,283 Total Patients Enrolled
4 Trials studying Migraine
2,723 Patients Enrolled for Migraine

Media Library

Ubrogepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05127954 — Phase 3
Migraine Research Study Groups: Ubrogepant Dose A (12 to 17 Years Old), Ubrogepant Dose B (6 to 11 Years Old)
Migraine Clinical Trial 2023: Ubrogepant Highlights & Side Effects. Trial Name: NCT05127954 — Phase 3
Ubrogepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127954 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT05127954 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
New York
Other
Florida
What site did they apply to?
Sunwise Clinical Research /ID# 238458
New England Institute for Clinical Research /ID# 239019
A.G.A Clinical Trials /ID# 238409
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
2
0

Why did patients apply to this trial?

La necesidad de dinero extra. because I can help other people and I also need the cash.
PatientReceived 1 prior treatment
Quiero saber mas de este ensayo clinico por mis dolores de cabeza. I have migraines. And they told me that I can get good money for doing clinical trials.
PatientReceived 2+ prior treatments
~689 spots leftby Mar 2027