Real World Efficacy, Tolerability and Safety of Ubrogepant
Chia-Chun Chiang1, Karissa Arca2, Rachel Dunn4, Marlene Girardo3, Jaxon Quillen3, David Dodick2, Amaal Starling2
1Neurology, Mayo Clinic, 2Neurology, 3Biostatistics, Mayo Clinic Arizona, 4Mayo Clinic Alix School of Medicine

To assess the real-world efficacy, tolerability and safety of ubrogepant in a tertiary headache center.


Ubrogepant was approved by the FDA in December 2019 for the acute treatment of migraine. There is currently no real-world data of ubrogepant use in a population with chronic migraine, multiple prior unsuccessful acute treatments, and concurrent use of CGRP monoclonal antibodies (mAbs).


This was a cohort study conducted at Mayo Clinic Arizona. All patients prescribed ubrogepant were contacted within three months to answer a list of standardized questions.


Eligible questionnaire responses were obtained from 106 patients, in which 92(86.8%) had chronic migraine, and 78(74%) had tried at least three triptans. Complete headache freedom and headache relief for ≥75% of all treated attacks at 2 hours after taking ubrogepant was achieved in 20(19.1%) and 50(47.6%) patients, respectively. Thirty-three (31.1%) patients were “very satisfied” with ubrogepant. Adverse events (AE) were reported in 42(39.6%) patients, including fatigue in 29(27.4%), dry mouth in 8(7.5%), nausea/vomiting in 7(6.6%), constipation in 5(4.7%), dizziness in 3(2.8%), and other AEs in 7(6.6%). Predictive factors for being a “good responder”, defined as headache relief for ≥75% of all treated attacks at 2 hours after taking ubrogepant, included migraine with aura, episodic migraine, <5 prior unsuccessful preventive or acute treatment trials, and successful responses to a CGRP mAb and onabotulinumtoxinA injections. For the 62 (58.5%) patients concurrently using a CGRP mAb, there was no difference in the “good responder” rate or AE rate compared to those who were not on a CGRP mAb, though the rate of AEs that were rated as moderate was higher, 11(47.8%) vs 3(17.6%), p=0.048.


Our study confirms and extends the efficacy profile and tolerability of ubrogepant in a real-world tertiary headache clinic, and identifies factors that may predict efficacy. Adverse event rates were higher than reported in clinical trials.