Ubrogepant for Migraine
(UNION Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBradley Torphy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Chicago Headache Center & Research Institute

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Research Team

Bradley Torphy, MD

Principal Investigator

Chicago Headache Center & Research Institute

Eligibility Criteria

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.

Inclusion Criteria

I experience 3 or more days of moderate to severe headaches each month.

My migraines usually last 4-72 hours and I have pain-free periods of at least 48 hours between them.

I have been on CGRP inhibitor treatment for more than a month.

See 2 more

Exclusion Criteria

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.

See 5 more

Treatment Details

Interventions

Ubrogepant (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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