Taken at onset, ubrogepant may stop migraine attacks in their tracks.
- 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.
Ubrogepant
as acute treatment for early-stage migraine attacks
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.
Participants
with migraine regain normal function within 2 hours from treatment
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.”
Who does this
research apply to?
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.
Expanding
treatment options for migraine
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.”
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