Vall d'Hebron leads an international phase III clinical trial demonstrating the efficacy of atogepant, an oral drug for the prevention of chronic migraine

Chronic migraine is characterized by the presence of 15 days a month with headache pain, which is very disabling and has a great impact on the quality of life of the people who suffer from it. Until now, these patients only had the option of injectable or intravenous treatments, but now an international phase III clinical trial in which the Headache and Neurological Pain group of the Vall d'Hebron Research Institute (VHIR) has participated has demonstrated the efficacy of the oral drug atogepant 60 mg for the prevention of migraine attacks in cases of chronic migraine. The results have been led by Dr. Patricia Pozo-Rosich, head of Section of the Neurology Service and Headache Unit at Vall d'Hebron University Hospital, head of the Headache and Neurological Pain group at VHIR and director of the Migraine Adaptive Brain Center at Vall d'Hebron and recently published in the journal The Lancet and have been possible thanks to the collaboration of more than 140 centers from 16 countries.

Atogepant is an inhibitor of the CGRP protein, which is released during migraine attacks. Recently, monoclonal antibodies that block CGRP have been approved and are bringing a therapeutic revolution for migraine patients, but, until now, it was only available in subcutaneous or intravenous injectable form. "Atogepant is the first oral drug that can be useful for patients with chronic migraine, which makes it easier to access, provides flexibility in drug administration and is easier to store, since injectable drugs usually need to be kept in a refrigerator", explains Dr. Patricia Pozo-Rosich.

This drug showed positive results in a study of patients with episodic migraine, that is, people who had less than 15 days of migraine per month. The aim of the study now being presented was to study its efficacy in the prevention of chronic migraine. To this end, the trial involved 778 people between 18 and 74 years old with chronic migraine, who were classified into three groups according to the medication they were taking. One group took 30 mg of atogepant twice a day, another group took 60 mg once a day and another group took a placebo.

The results of the study showed that people taking the drug had, on average, a reduction of seven days of migraine each month, regardless of whether they took 30 mg twice a day or 30 mg once a day. In contrast, people in the placebo group had only a reduction in five days of migraine per month. This difference is statistically significant. The study followed the patients for 12 months and confirmed that the improvement was maintained, especially in the group taking 30 mg twice a day.

"Chronic migraine is a very debilitating disease with a great impact on society, since it affects approximately 2% of the population and is the most serious expression of the disease", says Dr. Pozo-Rosich, who assures that "these results are encouraging, since we have observed that this treatment reduces the days on which people have migraine. This means an improvement in their quality of life".

On the other hand, it is also noteworthy that the fact of taking atogepant reduces the need to take medication to stop migraine attacks once they appear. In relation to the side effects of the medication, the most common were constipation or nausea, but none were found to be serious.

"We have confirmed that atogepant is a safe, well-tolerated and effective treatment for people with very disabling migraines. The results of this work offer new opportunities to prevent and treat these patients", says Dr. Pozo-Rosich.

A drug for the prevention also of episodic migraine that does not respond to treatment

Based on the good results of atogepant, the researchers have also analyzed its efficacy in patients with episodic migraine, who have fewer than 15 migraines per month, but do not respond to treatment (refractory migraine). The study was presented in April at the 75th Annual Meeting of the American Academy of Neurology.

In this case, the trial was conducted with 309 people who had at least four days of migraine per month and who had previously tried between two and four types of migraine prevention drugs, but without improvement. Half of them took atogepant orally while the other half took placebo in order to compare the results obtained.

The results of the study showed that people taking the drug had, on average, four fewer migraine days per month, while those taking the placebo had only two fewer migraine days per month. As with chronic migraine, it also highlights that taking atogepant reduces the need to take medication without observing serious side effects.

"We think that atogepant is a very complete drug. We are seeing that, thanks to its efficacy and tolerability, it is effective in all spectrums of the disease and will be useful for the prevention of migraine in a wide range of different types of patients", concludes Dr. Pozo-Rosich.