• J. Neurol. Neurosurg. Psychiatr. · Mar 2019

    Multicenter Study Clinical Trial

    Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety.

    • Andrew M Blumenfeld, Stewart J Tepper, Lawrence D Robbins, Manack Adams Aubrey A Allergan, Irvine, California, USA., Dawn C Buse, Amelia Orejudos, and D Silberstein Stephen S Department of Neurology, Jefferson Headache Center, Philadelphia, Pennsylvania, USA..
    • Headache Center of Southern California, The Neurology Center, Carlsbad, California, USA blumenfeld@neurocenter.com.
    • J. Neurol. Neurosurg. Psychiatr. 2019 Mar 1; 90 (3): 353-360.

    ObjectiveTo assess the effects of onabotulinumtoxinA treatment for chronic migraine (CM) on comorbid symptoms of depression, anxiety, fatigue and poor sleep quality.MethodsThe Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) study is a multicentre, open-label, prospective study assessing the long-term safety and efficacy of onabotulinumtoxinA 155 U over nine treatments (108 weeks) in adults with CM. The Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder (GAD-7) scales were used to assess the effects of onabotulinumtoxinA on comorbid symptoms of depression and anxiety, respectively. A clinically meaningful improvement was assessed by the percentage of patients experiencing a ≥1 severity category reduction in PHQ-9 and GAD-7. The effects of onabotulinumtoxinA on associated sleep quality and fatigue were assessed using the Pittsburgh Sleep Quality Index and Fatigue Severity Scale, respectively.ResultsOnabotulinumtoxinA treatment was associated with sustained reduction in headache days and PHQ-9 and GAD-7 scores in the analysis population (n=715) over 108 weeks. PHQ-9 and GAD-7 scores were significantly reduced at all time points in patients with clinically significant symptoms of depression and/or anxiety at baseline. By week 108, 78.0% and 81.5% had clinically meaningful improvement in depression and anxiety symptoms, respectively. Sleep quality and symptoms of fatigue also improved; however, less is understood about clinically meaningful changes in these measures. No new safety concerns were identified.ConclusionIn addition to reducing headache frequency, onabotulinumtoxinA treatment for CM was associated with clinically meaningful reduction in symptoms of depression and anxiety, and improved associated symptoms of poor sleep quality and fatigue.Trial Registration NumberNCT01516892.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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