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- W1657838061 abstract "Objective: Assess real-world efficacy and safety of onabotulinumtoxinA for the treatment of chronic migraine (CM), including patients with comorbid states of anxiety and/or depression.Background: Few CM treatment options are available, which are often further limited due to side effects. OnabotulinumtoxinA is approved for headache prophylaxis in CM and has demonstrated a favorable safety and efficacy profile; however, data are limited to 56 weeks. COMPEL was designed to evaluate the longer-term efficacy and safety of onabotulinumtoxinA for CM.Methods: This is a multicenter, open-label study in adult CM patients treated with 155U onabotulinumtoxinA every 12 weeks (NCT01516892). Change in frequency of headache days from baseline at 108 weeks (following 9 treatments) is the primary efficacy measure. Additional measures include headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), generalized anxiety disorder assessment (GAD-7), and patient health questionnaire (PHQ-9). Interim data to week 24 (following 2 treatments) are summarized using descriptive statistics. The safety cohort includes all patients receiving 蠅1 onabotulinumtoxinA treatment.Results: 713 enrolled patients who received study medication were 18-73 years old, predominantly female (N=603, 85[percnt]) and Caucasian (N=579, 81[percnt]). 691 patients included in the interim analyses reported an average 22 (SD=4.8) headache days per month at baseline. By week 24, a significant reduction (-7.6 days, p<0.0001) in number of headache days was observed (mean=14, SD=7.8). Patients also demonstrated significant improvements (p<0.0001) in HIT-6 (-5 point change) and MIDAS (-36 point change) scores from baseline, with moderate improvements in GAD-7 and PHQ-9 scores. A total of 106 (15[percnt]) patients reported 蠅1 treatment-related adverse events (TRAEs); 1 considered serious (rash). Most frequently reported TRAE was neck pain (N=21, 3[percnt])Conclusions: Consistent with previously published findings, interim data from COMPEL supports the efficacy and safety of onabotulinumtoxinA for headache prophylaxis in CM, up to 24 weeks.Study Supported by: Allergan, Inc. Disclosure: Dr. Blumenfeld has received personal compensation with Allergan, Zogenix, Inc., Depomed, Inc., Forest Laboratories, and Keller Labs as a speaker, advisory board member and/or consultant. Dr. Stark has received personal compensation for activities with Allergan, Inc., Merck Sharp & Dohme Ltd., Invivo, and Pfizer Inc. Dr. Reppine has received personal compensation for activities with Allergan, Inc. as an employee. Dr. Halstead has received personal compensation for activities with Allergan, Inc. as an employee. Dr. Holdbrook has received personal compensation for activities with Allergan, Inc. as an employee. Dr. Aurora has received personal compensation for activities with Merck, Allergan, and eNeura." @default.
- W1657838061 created "2016-06-24" @default.
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- W1657838061 date "2015-04-06" @default.
- W1657838061 modified "2023-09-24" @default.
- W1657838061 title "Efficacy and Safety of OnabotulinumtoxinA in a Long-Term, Open-Label Study for the Prophylaxis of Headaches in Adult Chronic Migraine Patients: An Interim Analysis of the COMPEL Study (P1.306)" @default.
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