In encouraging news for sufferers, recent research suggests that when taken at the first signs of a migraine, before headache pain begins, a drug called ubrogepant may be effective in helping those with migraine go about their daily lives with little or no symptoms.
The study focused on people who could tell when an attack was about to happen, due to early symptoms like sensitivity to light and sound, fatigue, neck pain or stiffness, or dizziness.
Ubrogepant is a calcitonin gene-related peptide receptor antagonist, or CGRP inhibitor. CGRP is a protein that plays a key role in the migraine process.
“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 study author Richard Lipton, MD, of Albert Einstein College of Medicine in New York, and Fellow of the American Academy of Neurology.
“Improving care at the first signs of migraine, even before headache pain begins, can be a key to improved outcomes. Our findings are encouraging, suggesting that ubrogepant may help sufferers to function normally and go about their day.”
The study involved 518 participants who had suffered from migraines for at least one year and two to eight migraine attacks per month in the three months before the study. All of them regularly experienced signs that a migraine would be starting within the next few hours. Participants were asked to treat two attacks during a two-month period.
Researchers divided participants into two groups. The first group received a placebo for their first set of pre-headache symptoms of migraine, followed by taking 100 mg of ubrogepant for their second instance of symptoms. The second group took ubrogepant for the first instance and placebo for the second instance.
Participants evaluated limitations on their activity in their diary using a scale ranging from zero to five, with zero meaning “not at all limited – I could do everything”; one, “a little limited”; two, “somewhat limited”; three, “very limited”; or four, “extremely limited”.
Twenty-four hours after taking the drug or a placebo, 65% of people who took ubrogepant reported themselves as “not at all limited – I could do everything”, or “a little limited”, compared wth 48% of those who took the placebo.
Researchers found that as early as two hours’ post-medication, people who took the drug were 73% more likely to report that they had “no disability, able to function normally” than those who took the placebo.
“Based on our findings, treatment with ubrogepant may allow sufferers who experience early warning signs to quickly treat migraine attacks in their earliest stages and continue their daily lives with little discomfort and disruption,” said Lipton. “This could lead to an improved quality of life for them.”
Participants showed that based on their headache warning symptoms, they could reliably predict impending migraine attacks These findings apply only to those with reliable warning symptoms.
A limitation of the study was that participants recorded their symptoms and medication use in electronic diaries, so it is possible some people may not have recorded all information accurately.
Study details
Effect of ubrogepant on patient-reported outcomes when administered during the migraine prodrome
Richard Lipton, Andrea Harriott, Julia Ma, David Dodick et al.
Published in Neurology on 28 August 2024.
Abstract
Background and Objectives
Ubrogepant is a calcitonin gene–related peptide receptor antagonist approved for the acute treatment of migraine. The PRODROME trial previously demonstrated that ubrogepant treatment during prodrome prevents the onset of moderate or severe headache. In this analysis of the PRODROME trial, the benefits of ubrogepant treatment during the prodrome on patient-reported outcomes (PROs) are evaluated.
Methods
PRODROME was a multicentre, randomised, double-blind, placebo-controlled, crossover trial that enrolled adults who experienced 2–8 migraine attacks per month with moderate-severe headache pain. Eligible participants treated 2 qualifying prodrome events, defined as a migraine attack with prodromal symptoms when the participant was confident a headache would follow within 1–6 hours. Participants were randomized to treatment sequence A (placebo then ubrogepant 100 mg) or sequence B (ubrogepant 100 mg then placebo). This analysis evaluated the ability to function normally over 24 hours (secondary end point) and at specific time points after dose (additional end point). Other PRO end points included activity limitation over 24 hours and satisfaction with study medication at 8 and 24 hours.
Results
Of 518 randomised participants, 477 comprised the modified intent-to-treat population. After treatment of qualifying prodrome events, a significantly greater ability to function normally over 24 hours was observed for participants after treatment with ubrogepant 100 mg compared with placebo (odds ratio [OR] 1.66, 95% CI 1.40–1.96; p < 0.0001). As early as 2 hours after dose, a greater proportion of ubrogepant-treated participants reported “no disability, able to function normally” compared with placebo (OR 1.76, 95% CI 1.32–2.35; nominal p = 0.0001). Ubrogepant administered during the prodrome was also associated with a greater reduction in activity limitations over 24 hours after dose (OR 2.07, 95% CI 1.61–2.67; nominal p < 0.0001). At 8 and 24 hours after dose, rates of being “satisfied” or “extremely satisfied” were greater for ubrogepant than for placebo (8 hours: OR 2.37, 95% CI 1.78–3.15; nominal p < 0.0001; 24 hours: OR 2.32, 95% CI 1.78–3.02; nominal p < 0.0001).
Discussion
Ubrogepant 100 mg administered during the prodrome was associated with significantly greater ability to function normally, greater reduction in activity limitations over 24 hours, and greater satisfaction with study medication, compared with placebo.
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