Ubrogepant efficacious, well tolerated for treating migraine in prodromal phase

Key takeaways:

• The study included 518 adults aged 18 to 75 years with at least a 1-year history of migraine.
• Adverse events were few 48 hours after treatment in ubrogepant and placebo populations.

Treatment with 100 mg ubrogepant was effective at curbing migraine attacks when administered during the prodromal phase compared with placebo, according to research from The Lancet.

“Although migraine attacks and treatment outcomes are often defined by the duration and severity of headache pain, attacks are known to occur in multiple phases,” David W. Dodick, MD, a vascular neurology specialist in the department of neurology at the Mayo Clinic, and colleagues wrote. “The prodrome is often the earliest phase and consists of various symptoms, including sensitivity to light, fatigue and neck pain.”

Researchers sought to evaluate safety, efficacy and tolerability of ubrogepant (Ubrelvy, AbbVie), a calcitonin gene-related peptide receptor agonist, compared with placebo administered during the prodromal phase of migraine.

Their study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover trial conducted at 75 research centers and headache clinics in the United States. It included a total of 518 adults aged 18 to 75 years with at least a 1-year history of migraine with or without aura, as well as two to eight documented moderate to severe migraine attacks per month at least 3 months before screening. Enrollees were randomly assigned 1:1 to receive either 100 mg ubrogepant or placebo to treat the first qualifying prodrome event, then 100 mg ubrogepant to treat the second qualifying prodrome event; or 100 mg ubrogepant to treat the first prodromal event and placebo to treat the second.

During the blinded treatment period, all participants were instructed to take two tablets by mouth at the onset of each qualifying prodrome event. There were a total of 4,802 events reported by 920 participants.

The primary endpoint was absence of moderate or severe intensity headache within 24 hours of self-administration; efficacy analyses were conducted with the modified intention-to-treat (mITT) population, defined as all randomly assigned participants with at least one headache assessment within 24 hours following ingestion. The safety population (480 participants) included all those who took at least one administration of the study drug, while the mITT population totaled 477 participants.

Dodick and colleagues wrote that absence of moderate or severe headache within 24 hours post-dose occurred after 190 of 418 qualifying prodrome events treated with ubrogepant and after 121 of 423 qualifying events treated with placebo (OR = 2.09, 95% CI, 1.63–2.69).

Adverse events that occurred within 48 hours after study-drug administration were reported after 77 of 456 qualifying prodrome events treated with ubrogepant and after 55 of 462 events treated with placebo.

“These data demonstrate the important role of Ubrelvy in treating migraine attacks early and reducing the overall burden of a migraine attack,” Dawn Carlson, vice president of neuroscience development at AbbVie, told Healio in an email.