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Monoclonal Antibodies
Ubrogepant for Migraine (UNION Trial)
Phase 4
Recruiting
Led By Bradley Torphy, MD
Research Sponsored by Chicago Headache Center & Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours after 2nd dose
Awards & highlights
UNION Trial Summary
This trial is comparing the effectiveness of two different doses of ubrogepant, a medication used to treat migraines, in patients who are also being treated with or without injectable CGRPmAbs (another medication used to treat migraines). The trial will involve patients recording information about their migraine symptoms and treatment response, and will compare the safety data with the original clinical trial.
Who is the study for?
Adults aged 18-75 with a history of migraines lasting between 4 and 72 hours, experiencing at least three moderate-severity migraine days per month. Participants may be on CGRPmAbs treatment for over a month. Excluded are those with significant health issues, pregnant or lactating women, users of certain drugs including preventative gepants or strong CYP3A4 inhibitors/inducers.Check my eligibility
What is being tested?
The study is testing two doses (50mg and 100mg) of Ubrogepant to treat a single migraine attack. It measures pain freedom and relief from the most bothersome symptom within two hours post-dosing. Patients will also record any need for a second dose and note adverse reactions.See study design
What are the potential side effects?
Possible side effects include nausea, sleepiness, dry mouth, and potential mild liver enzyme elevations. Side effects vary by individual experience but are generally considered tolerable based on previous trials.
UNION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours after 2nd dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours after 2nd dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from most bothersome symptom
Pain freedom
Secondary outcome measures
Pain relief at 2 hours
Pain relief at 2 hours after 2nd dose
Percentage of patients with sustained pain freedom from 2-24 hours after 2nd dose.
+3 moreUNION Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Tx w/ CGRPmAbActive Control2 Interventions
Tx w/ CGRPmAb
Group II: w/o CGRPmAbPlacebo Group2 Interventions
w/o CGRPmAb
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Who is running the clinical trial?
Chicago Headache Center & Research InstituteLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
AbbVieIndustry Sponsor
971 Previous Clinical Trials
504,964 Total Patients Enrolled
11 Trials studying Migraine
8,109 Patients Enrolled for Migraine
Bradley Torphy, MDPrincipal InvestigatorChicago Headache Center & Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience 3 or more days of moderate to severe headaches each month.You have used illegal drugs or had a problem with drugs or alcohol in the past year.I am currently receiving Botox for chronic migraines.I am currently using gepants to prevent my condition.My serious health conditions have been stable for over a year and won't affect my study participation.My migraines usually last 4-72 hours and I have pain-free periods of at least 48 hours between them.I am not taking strong medications like ketoconazole.I have been on CGRP inhibitor treatment for more than a month.I am between 18 and 75 years old.I have had migraines for at least a year.I experience less than 3 moderate to severe headaches a month.I am not taking medications like phenytoin or St. John's Wort.
Research Study Groups:
This trial has the following groups:- Group 1: w/o CGRPmAb
- Group 2: Tx w/ CGRPmAb
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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