Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies
Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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.