Symptoms improve quickly if medication is taken at the time of onset

The researchers who carried out this study wanted to investigate how using the drug ubrogepant during the prodromal phase of migraine improves functional outcomes.

The prodromal phase is the beginning of a migraine attack and can occur up to two days before the migraine-like phase kicks in. The study noted that prodromal symptoms can include irritability, fatigue, and photophobia (hypersensitivity to light).

This announcement is PRODROME StudyThis was a double-blind, randomized, placebo-controlled crossover study that included data from 73 different sites across the United States.

Participants were split into two groups. The first group received a placebo at the first prodrome and ubrogepant at the second prodrome. The second group received ubrogepant at the first prodrome and a placebo at the second prodrome.

The researchers defined a qualifying prodrome event as one in which prodrome symptoms were present and participants were confident that a headache would occur within 1 to 6 hours. All participants were between 18 and 75 years old and had a history of migraines for at least 1 year. All participants were able to identify prodrome symptoms.

The current analysis compared patient-reported outcomes associated with taking ubrogepant versus placebo. Researchers analyzed data from 477 participants in a modified intention-to-treat population.

The researchers examined participants' ability to function normally, activity limitations, and satisfaction with the results of their drug therapy.

Overall, the results demonstrated that ubrogepant was superior to placebo in terms of patient-reported outcome measures.

After 48 hours, more participants who received ubrogepant were able to function normally just two hours after taking it, compared to those who received a placebo.

Additionally, participants who received ubrogepant were more likely to have little or no activity limitations 24 hours after treatment. Participants who received ubrogepant were also more likely to report satisfaction with their medication.

Headache Neurologist Nina Riggins, MD, PhD, FAHSThe researcher, from the Headache Center at the Palo Alto VA Medical Center in California and a former researcher at Theranica and Eli Lilly, was not involved in the study. Today's Medical News that:

“Migraine is a genetic neurological disorder and there is currently no treatment that can stop migraines completely, so it is really important to find the most effective way to utilise the available treatments to enable patients with migraine to function well. […] In this RCT, participants took ubrogepant during prodromal symptoms compared with placebo [randomized control trial]Improved function over 24 hours, reduced activity limitations over 24 hours, [and] After 8 and 24 hours, more participants reported being satisfied with the study medication, which is great news. [it] Gives hope for prevention [the] “It's the headache stage.”

This study has several limitations. First, approximately 88% of participants were female and Caucasian, so in a real-life scenario, women represent the majority of migraine patients, but future studies could target a more diverse demographic.

Additionally, only about 85% of participants completed the study, and slightly more participants receiving ubrogepant experienced adverse events, such as nausea.

The researchers note that apart from the disability measure, other patient-reported outcome measures had a 24-hour recall period, which the researchers note could lead to recall bias.

The study authors also chose to measure functional ability over a 48-hour period and medication satisfaction and activity limitations over a 24-hour period, which may have limited the results. The authors could only infer the effect of ubrogepant at the time of evaluation.

The researchers also chose to include participants who met certain criteria, such as the ability to identify prodromal symptoms that precede the headache, occurring within one to six hours of the start of a migraine attack.

This time frame was also limited, but it allowed the researchers to gain clearer insight into the effectiveness of prodromal symptoms: participants were allowed to treat the same or different prodromal symptoms that could have altered the outcome response, and the researchers ruled out neck pain or stiffness as prodromal symptoms.

Finally, the study was funded by AbbVie, the pharmaceutical company that commercializes ubrogepant under the brand name “Ubrelvy.”

Additionally, the study authors have made several disclosures, including funding disclosures, that should be taken into consideration when considering the results.

Olivia Végasse de Dame, MD, FAHSFounder and medical director of the Headache and Brain Health Institute, who was not involved in the study, pointed to the study's limitations: MNT:

“There are limitations to being able to recognise prodromal symptoms and predict when a migraine will begin within one to six hours. At the moment it can be hard to tell whether a mild headache will turn into a full-blown attack, so it's already challenging to get the acute treatment you need as quickly as possible. [Furthermore,] Prodrome symptoms can be vague and not easy for patients to recognize, and not everyone with migraine has prodrome symptoms. Prodrome symptoms are not 100% predictive of the onset of the headache phase.”

“Another limitation is that we still have a lot to learn about the pathophysiology and mechanisms of the prodromal phase of a migraine attack,” Begasse de Dame pointed out.

“I believe ubrogepant was chosen for this treatment during the prodromal phase because of its overall tolerability and low risk of medication-overuse headache, but to my knowledge, the mechanism by which ubrogepant works when taken during the prodromal phase is still unknown,” she noted.

Regarding future research, Riggins said: […] if [the] Similar results would be seen with other acute migraine medications used during the prodrome.”

“I believe that further research will be conducted. [is] “We need to better understand the prodromal symptoms and see how often these symptoms are followed by headache during a migraine attack,” she added.

Overall, this study represents a potential new treatment approach for people suffering from migraines. The data presented here may help improve outcomes for people who have to deal with the severe pain and limitations associated with migraine attacks.

Dr. Medhat Mikhail“It's a pain-management specialist and medical director of the non-surgical program at the Spine Health Center at MemorialCare Orange Coast Medical Center in Fountain Valley, California, who was not involved in the study,” said. MNT that:

“This study was fantastic. [that] “When patients took ubrogepant early in the prodrome, their symptoms improved and, in most cases, did not progress to a full-blown migraine attack, and patients were able to maintain their function compared to patients in the comparison group who received a placebo. Clinically, this should guide clinicians in advising patients to discontinue medication very early, even at the onset of early symptoms, and to know and understand what the prodrome looks like.”