Absence of moderate or severe headache reported in 46 and 29 percent of prodrome events that had been treated with ubrogepant, placebo
WEDNESDAY, Nov. 22, 2023 (HealthDay News) — Ubrogepant is beneficial for the treatment of migraine when taken during the prodrome, according to a study published online Nov. 15 in The Lancet.
David W. Dodick, M.D., from the Mayo Clinic in Phoenix, and colleagues examined the efficacy, safety, and tolerability of ubrogepant 100 mg versus placebo for acute treatment of migraine when administered during the prodrome in a multicenter, randomized trial. Adults aged 18 to 75 years with at least a one-year history of migraine with or without aura and a history of two to eight migraine attacks per month with moderate-to-severe headache in the three months before screening were included. Participants were randomly assigned to placebo to treat the first qualifying prodrome event and ubrogepant 100 mg to treat the second qualifying prodrome event or vice versa. The safety population included 480 participants and the modified intention-to-treat population included 477 participants.
The researchers found that within 24 hours after a dose, absence of moderate or severe headache occurred after 46 and 29 percent of 418 and 423 qualifying prodrome events that had been treated with ubrogepant and placebo, respectively (odds ratio, 2.09). Adverse events that occurred within 48 hours after study-drug administration were reported after 17 and 12 percent of qualifying prodrome events that had been treated with ubrogepant and placebo, respectively.
“These results emphasize the clinical value of identifying the prodrome in people with migraine and highlight an important opportunity to intervene in the earliest phase of a migraine attack to prevent progression to the headache phase, reduce disability, and improve outcomes,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including AbbVie, which manufactures ubrogepant and funded the study.