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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 weeks
Treatment ~ Varies
Follow Up ~2 hours after 2nd dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours after 2nd dose for reporting.

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 more

UNION 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

Find a Location

Who is running the clinical trial?

Chicago Headache Center & Research InstituteLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,226 Total Patients Enrolled
10 Trials studying Migraine
7,659 Patients Enrolled for Migraine
Bradley Torphy, MDPrincipal InvestigatorChicago Headache Center & Research Institute

Media Library

Ubrogepant (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05503082 — Phase 4
Migraine Research Study Groups: w/o CGRPmAb, Tx w/ CGRPmAb
Migraine Clinical Trial 2023: Ubrogepant Highlights & Side Effects. Trial Name: NCT05503082 — Phase 4
Ubrogepant (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05503082 — Phase 4

Frequently Asked Questions

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

What are the primary objectives of this research endeavor?

"This experiment, which will be evaluated two hours after the intervention is applied, seeks to determine Freedom from most bothersome symptom. Secondary goals include gauging Percentage of patients with sustained pain relief from 2-24 hours post second dose., Percentage of patients with sustained pain freedom over a similar time range, and Pain relief at 2 hours (not necessarily total abatement)."

Answered by AI

Is the enrollment window currently available for prospective participants?

"Contrary to what is posted on clinicaltrials.gov, this investigation has concluded its search for participants; the study was initially shared August 1st 2022 and last updated August 14th 2022. While no longer recruiting patients, there are still 260 other trials that require volunteers at present."

Answered by AI

Is my involvement in this experiment possible?

"This medical trial seeks 164 applicants who suffer from frequent headaches/migraines and are 18-75 years old."

Answered by AI

How secure are the outcomes of treatment with CGRPmAb for individuals?

"There is ample evidence supporting the safety of Tx w/ CGRPmAb, thus it received a rating of 3 on our scale. This medication has already gone through Phase 4 trials and been approved for use."

Answered by AI

Are elderly individuals eligible to participate in this experiment?

"To be considered for this trial, one must fall between 18 and 75 years old. Moreover, there are 43 seperate clinical trials catering to patients younger than 18 as well as 178 studies aimed towards those over 65."

Answered by AI
~0 spots leftby May 2024