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Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies
Sponsor: Chicago Headache Center & Research Institute
Summary
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.
Official title: Ubrogepant Efficacy and Safety in the Treatment of Acute Migraine in Patients Currently Treated With CGRP Monoclonal Antibodies (CGRPmAbs)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2022-09-06
Completion Date
2024-11
Last Updated
2024-08-20
Healthy Volunteers
No
Conditions
Interventions
Ubrogepant 50 MG [Ubrelvy]
Ubrogepant 50 MG \[Ubrelvy\]
Ubrogepant 100 MG [Ubrelvy]
Ubrogepant 100 MG \[Ubrelvy\]
Locations (2)
Chicago Headache Center & Research Institute
Chicago, Illinois, United States
Chicago Headache Center & Research Institute
Naperville, Illinois, United States