P083 | EFFECT OF ATOGEPANT ON COGNITIVE FUNCTION FOLLOWING ACUTE TREATMENT OF MIGRAINE ACROSS MULTIPLE ATTACKS: RESULTS FROM THE ECLIPSE TRIAL
R. Masselli1, A. Van Dycke2, G. Ahmadyar3, E. Brand-Schieber3, C. Castro3, R. Ornello4, L. Luo3, P. Pozo-Rosich5|6, U. Reuter7|8, K. Carr3, R. Gil-Gouveia9|10 | 1AbbVie Srl, Rome, Italy; 2Department of Neurology, General Hospital Sint-Jan Bruges, Belgium; 3AbbVie Inc. North Chicago, IL, USA; 4Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy; 5Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Headache and Neurological Pain Research; 6Headache and Neurological Pain Research Group, Vall d'Hebron Institute of Research, Universitat Autonoma de Barcelona, Spain; 7University Hospital Bonn, Germany; 8Charité Universitätsmedizin Berlin, Germany; 9Neurology Department, Hospital da Luz, Lisboa, Portugal; 10Center for Interdisciplinary Research in Health, Universidade Católica Portuguesa, Lisboa, Portugal
Abstract
Background. 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); this effect increased over time through 4- and 8-hours postdose (OR: 3.39, 3.73, respectively). A similar reliable response was observed across attacks 2-4 ().
Conclusions. 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.
Raffaello Masselli, this individual has been added to this publication author by-line, with the permission of the original authors, for the express purpose of conducting the presentation at a local congress or in a local language. He did not contribute to the content of the publication.
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); this effect increased over time through 4- and 8-hours postdose (OR: 3.39, 3.73, respectively). A similar reliable response was observed across attacks 2-4 ().
Conclusions. 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.
Raffaello Masselli, this individual has been added to this publication author by-line, with the permission of the original authors, for the express purpose of conducting the presentation at a local congress or in a local language. He did not contribute to the content of the publication.
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