Single-Dose Infusion Reduces Migraine Frequency in Phase 2 Trial
Intravenous Lu AG09222 reduced migraine frequency over 4 weeks in patients who had failed to find relief with previous treatments, according to a phase 2 trial published in the New England Journal of Medicine.
Lu AG09222 is a humanized monoclonal antibody directed against the pituitary adenylate cyclase–activating polypeptide ligand. The study sought to investigate the efficacy and safety of the novel agent for migraine prevention.
The double-blind, placebo-controlled trial included 237 adults with migraine who did not benefit from 2 to 4 previous preventive treatments. In a 2:1:2 ratio, participants were randomly assigned to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo.
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The study’s primary endpoint was the mean change from baseline to week 4 in the number of migraine days per month with 750-mg Lu AG09222 compared with placebo. In addition to the 4 week treatment period, the study included an 8-week follow-up period.
At baseline, the mean number of baseline migraine days per month in the overall population was 16.7. Over weeks 1 through 4 of the study, the Lu AG09222 750-mg group experienced 6.2 fewer days of migraine, on average, compared with an average 4.2 fewer migraine days for the placebo group, researchers reported.
Over the 12-week observation period, adverse events that occurred more frequently in the Lu AG09222 750-mg group than the placebo group included COVID-19 (7% vs 3%), nasopharyngitis (7% vs 4%), and fatigue (5% vs 1%), according to the study.
“In a phase 2 trial, a single intravenous infusion of 750 mg of Lu AG09222 showed superiority over placebo in reducing migraine frequency over the subsequent 4 weeks,” wrote corresponding author Messoud Ashina, MD, of the Danish Headache Center at Copenhagen University Hospital–Rigshospitalet, Glostrup, Denmark, and study coauthors.
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