- Migraine attacks are painful events that can cause many unpleasant symptoms.
- Research is ongoing about the best way to help people who experience migraine attacks.
- Results of a recent study found that administering the medication ubrogepant during the prodrome, or ‘onset,’ phase of migraine may greatly improve normal functioning abilities and reduce activity limitations.
Migraine is a common condition, and migraine attacks are events that often involve severe headache pain that inhibits a person’s ability to go about everyday activities.
Attacks can be challenging to treat, and experts are interested in how medications can help and how timing can increase their effectiveness.
A study published in Neurology analyzed the effects of the medication ubrogepant when participants took it just before a migraine occurred.
Participants who received ubrogepant were more likely to report an ability to function normally and fewer activity limitations than participants taking the placebo.
They were also more likely to report being satisfied with the medications’ results than those who received the placebo. The results point to the effectiveness of taking ubrogepant during the prodrome, or ‘onset,’ period of a migraine attack.
The researchers who conducted this study wanted to look at how using the medication ubrogepant during the prodromal phase of migraine could help improve functional outcomes.
The prodromal phase is the very beginning of a migraine episode, which can happen as early as 2 days before the headache-like stage of migraine begins. This study notes that symptoms during the prodromal phase can include irritability, fatigue, and photophobia, or sensitivity to light.
The current publication was an analysis of a previous trial called the PRODROME trial. This was a double-blind, randomized, placebo-controlled crossover trial that included data from 73 different sites across the United States.
Participants were divided into two groups. The first group received the placebo at the first prodrome event and then ubrogepant at the second prodrome event. The second group received ubrogepant for the first event and the placebo for the second.
Researchers defined a qualifying prodrome event as having prodromal symptoms coupled with the participants being certain that a headache would follow within 1 to 6 hours. All participants were between 18 and 75 years old and had a 1-year history or more of migraine. All participants were able to identify prodrome symptoms.
The current analysis looked at the patient-reported outcomes related to taking ubrogepant compared to the placebo. Researchers analyzed data from 477 participants in the modified intent-to-treat population.
They looked at participants’ ability to function normally, activity limitation, and satisfaction with medication results.
Overall, the results demonstrated that ubrogepant was superior to placebo in terms of patient-reported outcome measurements
Over 48 hours, more participants who received ubrogepant were able to function normally in as little as 2 hours from receiving ubrogepant compared to those who received the placebo.
In addition, participants who received ubrogepant were more likely to have little to no activity limitations at 24 hours from treatment. Participants receiving ubrogepant were also more likely to report satisfaction with the medication treatment.
Headache neurologist Nina Riggins, MD, PhD, FAHS, from the Headache Center of Excellence of Palo Alto VA Medical Center in California, who previously conducted research for Theranica and Eli Lilly, but was not involved in the current study, noted to Medical News Today that:
“Migraine is a genetic neurologic disorder, and, so far, we don’t have treatment to completely stop migraine disease, so it is very important to figure out the best way to use available treatments to allow patients living with migraine to function well […] Ubrogepant intake in comparison to placebo, when participants took it during prodrome in this RCT [randomized control trial], resulted in improved functioning for over 24 hours, decrease in activity limitations at 24 hours, [and] more participants reported satisfaction with study medication at 8 and 24 hours. This is great news, as [it] gives us hope to prevent [the] headache stage.”
This research does have some limitations. First, approximately 88% of participants were female and white, so future research could include a more diverse demographic, although women do make up the majority of the demographic with migraine in real-world scenarios.
Additionally, only about 85% of participants completed the trial, and slightly more participants receiving ubrogepant had adverse events like nausea.
Researchers note that, apart from the disability measurement, other patient-reported outcome measures had 24-hour recall times. They note that this could lead to recall bias.
The study authors also chose to measure function ability over 48 hours, and medication satisfaction and activity limitations over 24 hours, which could have limited the results. They could only really draw inferences about uobrogepant’s benefits at the time of the assessments.
The researchers also chose to include participants who met specific criteria, such as their ability to identify prodrome symptoms that preceded a headache that occurred 1 to 6 hours from migraine attack onset.
This time window was also limiting, but it provides researchers with more definitely insight into prodrome efficacy. Participants were allowed to treat the same or different prodromal symptoms, which could have changed outcome responses, and researchers excluded neck pain or neck stiffness as prodromal symptoms.
Finally, this study received funding from pharmaceutical company AbbVie, which commercializes ubrogepant under the brand name Ubrelvy.
Moreover, the study authors made several disclosures, including funding support disclosures, which should be taken into account when considering the results
Olivia Begasse de Dhaem, MD, FAHS, founder and medical director of the Institute for Headache and Brain Health, who was not involved in this study, noted the following limitations of the research to MNT:
“Some limitations involve recognizing the symptoms of the prodrome and being able to estimate that a migraine headache would start in 1-6 hours. It is already not easy to take as needed acute treatments as early as possible because it may be hard at times to recognize whether this currently mild headache would turn into a full blown attack. [Furthermore,] recognizing the prodromal symptoms, which sometimes can be vague, may not be easy for people. Not everyone with migraine has prodromal symptoms either. Prodromal symptoms may not be 100% predictive of a headache phase coming.”
“Another limitation is that we are still learning about the pathophysiology, the mechanisms, of the prodromal phase of migraine attacks,” Begasse de Dhaem noted.
“I think ubrogepant was chosen for such an approach during the prodromal phase because of its overall tolerability and low risk of medication overuse headache, but as far as I know, we don’t know yet by what mechanism ubrogepant taken in the prodromal phase would work,” she pointed out.
Riggins noted that, insofar as future research is concerned, “it will be very interesting to determine […] if [the] use of other acute migraine medications will show similar results when used during prodrome.”
“I believe more future research [is] needed to make sure that we better understand prodromal symptoms and how often headache follows these symptoms during migraine attacks,” she added.
Overall, the current research presents another potential treatment approach for people who experience migraine headaches. The data presented here could help improve outcomes for people who have to deal with the severe pain and limitations that can accompany migraine attacks.
Medhat Mikhael, MD, pain management specialist and medical director of the nonoperative programme at the Spine Health Center at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, who was not involved in the study, told MNT that:
“The study was great because it showed [that] when the patient took the ubrogepant early on during the prodrome it improved the symptoms and in most of the cases it did not proceed into a full-blown migraine episode and kept that patient functional vs the comparing group of patients that received placebo. Clinically, that would guide clinicians to advise their patients to take the abortive medications very early on even at the onset of early first symptoms and know and understand what prodrome symptoms are.”
