The following article is part of conference coverage from the 2019 American Academy of Neurology Annual Meeting (AAN 2019) in Philadelphia, PA. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2019.
PHILADELPHIA — Individuals treated with ubrogepant for the acute treatment of migraine reported improvements in migraine-associated pain and functional disability, as well as general satisfaction with treatment, according to the results of two phase 3 studies presented at the 2019 American Academy of Neurology annual meeting, held May 4-10 in Philadelphia, Pennsylvania.
Ubrogepant is a small molecule antagonist of the calcitonin gene-related peptide receptor. With these 2 multicenter randomized double-blind pivotal phase 3 studies, ACHIEVE I and II (Clinicaltrials.gov identifiers NCT02828020 and NCT02867709, respectively), investigators sought to examine the effects of ubrogepant administered orally for the acute treatment of a single migraine attack with or without aura. In particular, functional disability was assessed by participants using a single-item scale with 4 options evaluating the effect on the performance of daily activities. Satisfaction with the treatment and “global impression of change” were evaluated with 2 rating scales (7 points each). Outcomes
were assessed 2 hours after treatment administration.
In the ACHIEVE I study, participants (n=1327) were randomly assigned to receive ubrogepant 50 mg or 100 mg or placebo, and in the ACHIEVE II trial (n=1355), ubrogepant 25 mg, 50 mg, or placebo.
In both studies, a greater percentage of participants treated with ubrogepant vs placebo2 hours after administration reported: normal functioning (ACHIEVE I: ubrogepant 50 mg, 41%; P =.0012; ubrogepant 100 mg, 43%; P <.0001; ACHIEVE II: ubrogepant 25 mg, 43%; P =.0015; ubrogepant 50 mg, 41%; P =.0118); (extreme) satisfaction with ubrogepant (ACHIEVE I: ubrogepant 50 mg, 36%; P <.0001; ubrogepant 100 mg, 36%; P =.0002; ACHIEVE II: ubrogepant 25 mg, 35%; P =.0018; ubrogepant 50 mg, 38%; P <.0001); migraine much or very much improved (ACHIEVE I: ubrogepant 50 mg, 34%; P =.0006; ubrogepant 100 mg, 34%; P =.0009; ACHIEVE II: ubrogepant 25 mg, 34%; P <.0001; ubrogepant 50 mg, 33%; P =.0002).
A greater percentage of patients treated with ubrogepant vs placebo reported at 2 hours post-administration freedom from pain (ACHIEVE I: ubrogepant 50 mg, 19%; P =.0023; ubrogepant 100 mg, 21%; P =.0003; ACHIEVE II: ubrogepant 25 mg, 21%; P =.0285; ubrogepant 50 mg, 22%; P =.0129), as well as pain relief (ACHIEVE I: ubrogepant 50 mg and 100 mg, 61%; P =.0023; ACHIEVE II: ubrogepant 25 mg, 61%; P =.0711; ubrogepant 50 mg, 63%; P =.0129).
“The results of these patient-centered outcomes were found to be clinically meaningful and reinforce the potential benefits of ubrogepant in the acute treatment of migraine,” noted the investigators.
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Viswanathan HM, Lipton RB, Ailani J, et al. Improved functionality, pain relief, and satisfaction in patients treated with ubrogepant vs placebo: Results from 2 single attacks phase 3 studies ACHIEVE I and II. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, Pennsylvania.