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.
The current publication was an analysis of a previous trial called the PRODROME trial.
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 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. 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.
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. Another limitation is that we are still learning about the pathophysiology, the mechanisms, of the prodromal phase of migraine attacks. 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. 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.
