Ubrogepant may stop migraine before headache onset

Key takeaways:

• Prodromal treatment with ubrogepant led to better overall outcomes post dose.
• Patient satisfaction with ubrogepant was greater compared with placebo.

Prodromal treatment with 100 mg ubrogepant was associated with greater functionality, fewer activity limitations and a high degree of satisfaction at 24 hours in patients with migraine, according to research published in Neurology.

“Treatment with ubrogepant may allow people with migraine who experience early warning signs before a migraine occurs to quickly treat migraine attacks in their earliest stages and go about their daily lives with little discomfort and disruption,” Richard B. Lipton, MD, a professor of neurology at Albert Einstein College of Medicine, said in a related press release. “This could lead to an improved quality of life for those living with migraine.”

Lipton and colleagues examined the effects of ubrogepant (Ubrelvy, Abbvie) during the prodromal phase of migraine on patient-reported outcomes in the PRODROME study.

PRODROME was a multicenter, randomized, double-blind, placebo-controlled, crossover clinical trial conducted at 73 locations in the United States that enrolled 518 adults with at least a 1-year history of migraine who experienced two to eight attacks per month with moderate to severe associated pain.

All the participants received treatment for two qualifying prodromal events, where migraine was certain to occur within 1 to 6 hours. They were randomly assigned 1:1 to receive either treatment sequence A (placebo, then ubrogepant 100 mg) or sequence B (ubrogepant 100 mg followed by placebo).

The primary endpoints were assessments of safety, efficacy and tolerability of the treatment, with secondary endpoints including functionality after 24 hours, as well as during prespecified post-dose intervals. The researchers also logged data concerning medication satisfaction at 8 and 24 hours along with 24-hour activity limitations.

A total of 477 participants comprised the modified intent-to-treat population.

According to the results, treatment with ubrogepant led to greater functional ability (OR = 1.66; 95% CI, 1.4–1.96) compared with placebo, with no disability recorded as early as 2 hours post dose (OR = 1.76; 95% CI, 1.32–2.35).

Prodromal treatment was also associated with a greater reduction in 24-hour post dose activity limitations (OR = 2.07; 95% CI, 1.61–2.67), with patient satisfaction greater for ubrogepant than for placebo at both 8 and 24 hours (8 hours: OR = 2.37; 95% CI, 1.78–3.15; 24 hours: OR = 2.32; 95% CI, 1.78–3.02).

“Gepants have a number of advantages for treatment during the prodrome,” Lipton and colleagues wrote. “These medications are well-tolerated and have not been associated with an increased risk of medication overuse.”

Reference:

• New study: Drug may stop migraines before headache starts. https://www.aan.com/PressRoom/Home/PressRelease/5195. Published Aug. 28, 2024. Accessed Aug. 29, 2024.