Ubrogepant Offers Early Relief for Migraine Sufferers

New research highlights the effectiveness of ubrogepant in treating migraines during the prodrome phase. The study was published in Neurology.

The need for more effective migraine treatments

Migraines are common headache disorders that affect an estimated 1.1 billion individuals worldwide. Characterized by episodic one-sided head pain, which can be accompanied by nausea, vomiting and sensitivity to light and sound, the condition typically lasts for 4–72 hours. The prodromal phase of a migraine is the earliest phase of the disorder and usually occurs within four to six hours of headache onset. Clinical studies have found patients with severe migraine attacks experience a higher burden of prodrome symptoms and those that have a high frequency of these symptoms often experience longer and more severe migraine episodes.

Current migraine treatments include medications that manage symptoms, such as painkillers, anti-nausea tablets or triptans (which target overactive pain nerves). Although the availability of migraine treatments has improved, over 95% of people taking an orally administered acute prescription medication for headaches, have at least one unmet acute treatment need.

“A migraine is one of the most prevalent diseases worldwide, yet so many people who suffer from this condition do not receive treatment or report that they are not satisfied with their treatment,” said lead author Dr. Richard B. Lipton, the Edwin S. Lowe professor and vice chair of neurology, professor of epidemiology and population health and professor of psychiatry and behavioral sciences at the Albert Einstein College of Medicine.

Ubrogepant is effective during the prodrome phase

Calcitonin gene-related peptide (CGRP) is a neuropeptide that plays an important role in the pathogenesis of a migraine. Small‐molecule CGRP receptor antagonists, such as ubrogepant, are also approved by the Food and Drug Administration (FDA) for the acute treatment of the headache disorder.

The PRODROME trial was a double-blind, placebo-controlled, phase 3 clinical study that evaluated the efficacy, safety and tolerability of ubrogepant (100 mg) compared with placebo, for the acute treatment of migraines when administered during the prodrome phase.

The study involved 518 participants who had 2–8 migraine episodes per month in the 3 months before the study. Eligible participants experienced prodromal symptoms that implied a headache would follow within one to six hours.

The participants were split into two groups. The first group received a placebo during the prodrome phase, followed by taking 100 mg of ubrogepant for their second instance of symptoms. The second group received ubrogepant during the prodrome phase and placebo for the second instance. Participants were then asked to evaluate limitations on their activity in their diary.

The trial results found the drug was effective and well tolerated for the treatment of migraine attacks when taken during the prodrome. Lipton and team further analyzed the results from the PRODROME trial to calculate the benefits of ubrogepant treatment on patient-reported outcomes.

After treatment, 65% of patients who were administered ubrogepant reported they were “not at all limited – I could do everything” or “a little limited,” compared with 48% of those who took the placebo. Patients in the treatment arm were also 73% more likely to report an ability to function normally after just two hours compared to the placebo.

Ubrogepant could lead to an improved quality of life

“Based on our findings, treatment with ubrogepant may allow people with migraines 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,” said Lipton.

“This could lead to an improved quality of life for those living with migraine,” he added.

While the study demonstrated the efficacy of ubrogepant in treating migraines during the prodrome phase, further research is necessary to better understand the prevalence of prodromal symptoms and to evaluate the drug's effectiveness in patients who do not experience these symptoms.

Reference: Lipton RB, Harriott AM, Ma JY, et al. Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome. Neurology. 2024;103(6):e209745. doi: 10.1212/WNL.0000000000209745

This article is a rework of a press release issued by the American Academy of Neurology. Material has been edited for length and content.