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AAN 2021 | Atogepant meets all endpoints in the Phase III ADVANCE trial for episodic migraine prevention

Atogepant is an oral calcitonin gene–related peptide (CGRP) receptor antagonist, known as a gepant, currently under investigation for the preventive treatment of migraine. Jessica Ailani, MD, FAAN, Medstar Georgetown University Hospital, Washington, DC, shares the findings of the Phase III randomized, controlled ADVANCE trial (NCT03777059), evaluating the safety and efficacy of atogepant in patients with episodic migraine. Over 900 patients were randomized to receive atopgepant at one of three dose levels, or placebo, for 12 weeks. The results showed that in all 3 dose groups, atogepant met its primary outcome of a statistically significant reduction in migraine days compared to placebo. At the higher dose levels of 30mg and 60mg daily, all secondary endpoints were also met, including reduced acute medication use, reduction in physical impairment, ≥50% response rate, and improved quality of life. This interview took place during the American Academy of Neurology (AAN) 2021 Annual Meeting.

Transcript (edited for clarity)

So as I mentioned, atogepant just completed a Phase III trial in patients with migraine. These were patients who had, what we consider, episodic migraine. They have less than 15 days a month of headaches, somewhere between four to 14 days of migraine, and in this trial, approximately seven to eight days a month of migraine.

Atogepant was studied compared to placebo and there were three different dosing options for atogepant, either 10 milligrams once a day, 30 milligrams once a day or 60 milligrams once a day...

So as I mentioned, atogepant just completed a Phase III trial in patients with migraine. These were patients who had, what we consider, episodic migraine. They have less than 15 days a month of headaches, somewhere between four to 14 days of migraine, and in this trial, approximately seven to eight days a month of migraine.

Atogepant was studied compared to placebo and there were three different dosing options for atogepant, either 10 milligrams once a day, 30 milligrams once a day or 60 milligrams once a day. They didn’t have to titrate up, so if were on 60 you started at 60, if you were on 30 you started on 30. So that was really nice. That’s, I think important for patients in the future. If this is approved, nobody likes to titrate doses. To just be able to go straight on the dose is a nice option.

This was a 12 week trial, so three months, where patients were looked at if they took atogepant or placebo, did they have a reduction in migraine headache days during the time of the trial? So that was the primary end point. There was a number of secondary end points. They were taking a look at improvement in headache days, what percent of patients had a greater than 50% response rate during the time period of the study, and then also quality of life factors. So what percent of patients had improved quality of life, had improvement in performance of daily activities and had a reduction in physical impairment that relates to migraine? All extremely important factors when it comes to clinical practice when we’re seeing patients in our clinic. They also looked at acute medication use and what percent of patients had a reduction in the acute medication use.

So atogepant, for all three doses, met its primary endpoint of reduction in migraine days during the time of the trial and the findings were statistically significant. They found that for doses of 10 milligrams it was about 3.69 days less compared to placebo at about 2.48 days less. For 30 milligrams it was 3.86 days less of migraine and for 60 milligrams, 4.2 days less. So pretty significant difference compared to placebo. For doses of 30 and 60 milligrams, they met all secondary end points. The 10 milligrams, however, missed on one of the secondary end points. We also know that it meant that 50% or greater response rate, and we could actually see results happen as soon as the first week and this did separate from placebo. So it was pretty exciting findings for this Phase III clinical trial.

Side effects in this study were mainly seen to be constipation and nausea. And when we look at the gepant class, this seems to be similar, especially when we look at the medication ubrogepant, which is on the market, we can see a little bit of a signal of nausea on this medication when we look at the side effect profile that is seen in clinical practice.

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Disclosures

Consulting: (Honoraria for independent consulting) Amgen, Abbvie, Biohaven, Eli Lilly and Company, Lundbeck, Teva, Impel, Satsuma, Theranica, Axsome, Neso, GlaxoSmithKline, Aeon, Medscape
Ownership of Stocks: CtrM
Speakers Bureau: (Honoraria for promotional speaking) Allergan/Abbvie, Amgen, Biohaven, Eli Lilly and Company, Lundbeck, Teva
Editorial services: (Honoraria) Current Pain and Headache Reports, Section editor, Unusual Headache Syndromes, NeurologyLive, SELF (medical reviewer)
Clinical Trial Grants: (Fees to Institution) American Migraine Foundation, Allergan, Biohaven, Eli Lilly and Company, Satsuma, Zosano