Ubrogepant Eases Prodromal Migraine Symptoms
The clinical utility of the calcitonin gene–related peptide (CGRP) receptor antagonist ubrogepant may extend beyond the treatment of acute migraine to alleviating common prodromal symptoms of migraine, according to an exploratory analysis from the phase 3 PRODROME trial.
Taken during the prodromal phase of migraine, ubrogepant led to improvements in concentration, as well as reduced sensitivity to light and sound, neck pain, fatigue, and dizziness — with some improvements occurring as soon as 1 hour after dosing.
Ubrogepant (Ubrelvy) was approved in the United States for the acute treatment of migraine with, or without, aura in adults in 2019. It is not indicated for migraine prevention.
The new data suggest ubrogepant administered in the premonitory (prodromal) phase of migraine, before a headache starts, may help resolve common prodromal symptoms, such as photophobia, phonophobia, and cognitive dysfunction.
Led by Peter Goadsby, MBBS, MD, PhD, professor of neurology, King's College London, London, England, the study was published online on May 12 in Nature Medicine .
Clinically Relevant Data
The PRODROME trial enrolled 438 adults with at least 1-year history of migraine who could identify prodromal symptoms predictive of a headache within 1-6 hours.
Each participant took a 100-mg dose of ubrogepant or placebo during one prodromal event, followed by the alternate treatment during a second prodromal event at least 7 days later.
After dosing, ubrogepant was more effective than placebo on the outcomes of absence of photophobia at 2 hours (19.5% vs 12.5%; odds ratio [OR], 1.72), fatigue at 3 hours (27.3% vs 16.8%; OR, 1.85), neck pain at 3 hours (28.9% vs 15.9%; OR, 2.04), phonophobia at 4 hours (50.7% vs 35.8%; OR, 1.97), and dizziness at 24 hours (88.5% vs 82.3%; OR, 1.82).
Ubrogepant was also better than placebo in terms of absence of difficulty concentrating at 1 hour (8.7% vs 2.1%; OR, 4.26) and difficulty thinking at 6 hours (56.9% vs 41.8%; OR, 2.05).
Treatment-emergent adverse events were mild and slightly more common in the ubrogepant group (17% vs 12%).
The authors noted that 32%-57% of premonitory symptoms were moderate to severe in intensity and associated with functional disability.
'As premonitory symptoms can be disabling, their treatment alone is clinically relevant, beyond the consideration that treatment during the prodrome prevents headache onset and improves function over 24-48 hours, as demonstrated in the primary analysis of the study,' the investigators wrote.
'Greater awareness of the clinical symptomatology of the prodromal phase, as well as the availability of effective treatment, offers a major opportunity to improve the treatment of acute migraine,' they concluded.
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