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Effect of atogepant on cognitive function following acute treatment of migraine across multiple attacks: results from the ECLIPSE trial
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Background and aims: Atogepant is approved for the preventive treatment of migraine in adults and has recently demonstrated its efficacy and safety for the acute treatment of migraine. This analysis evaluated the impact of atogepant 60mg administered as needed (PRN) for acute treatment of migraine on cognitive function assessed by the ability to think clearly. Methods: ECLIPSE was a double-blind (DB), placebo-controlled, multiple-attack, crossover trial evaluating atogepant's efficacy, safety, and tolerability for acute migraine treatment. Adults with 2–8 monthly moderate-to-severe attacks were randomised to receive atogepant for three qualifying attacks and placebo for one attack during the up to 16-week DB period. Cognitive function scale is a single-item, patient-reported questionnaire measuring participants' difficulty in ability to think clearly, rated from 0 (not difficult at all) to 3 (very difficult). The proportion of participants achieving the ability to think clearly at 2-, 4-, and 8-hours postdose across attacks 1–4 was an additional (exploratory) efficacy endpoint. Data for atogepant and placebo are presented with nominal p-values. Results: Atogepant treatment resulted in a nominally significant higher proportion of participants achieving the ability to think clearly compared with placebo as early as 2-hours postdose in the first treated attack (OR: 1.78, Figure 1); this effect increased over time through 4- and 8-hours postdose (OR: 3.39, 3.73, respectively; Figure 1). A similar reliable response was observed across attacks 2–4 (Figure 2). Conclusion: A greater proportion of participants treated with atogepant achieved the ability to think clearly compared to placebo as early as 2-hours and up to 8-hours postdose across multiple attacks.
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John Wiley and Sons Inc.