Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study.
Ontology highlight
ABSTRACT: OnabotulinumtoxinA is approved for the prevention of headache in those with chronic migraine (CM); however, more clinical data on the risk-benefit profile for treatment beyond one year is desirable.The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) Study ( ClinicalTrials.gov , NCT01516892) is an international, multicenter, open-label long-term prospective study. Adults with CM received 155 U of onabotulinumtoxinA (31 sites in a fixed-site, fixed-dose paradigm across 7 head/neck muscles) every 12 weeks (±7 days) for 9 treatment cycles (108 weeks). The primary outcome was headache day reductions at 108 weeks; secondary outcomes were headache day reductions at 60 weeks and change in the 6-item Headache Impact Test (HIT-6) score. Safety and tolerability were assessed by reviewing the frequency and nature of adverse events (AEs). AEs were determined at each visit through patient self-report, general non-directed and, for specific AEs, directed questioning, and physical examination. Subgroup analyses for safety and efficacy included, but were not limited to, patients with/without concomitant oral preventive treatment and acute medication overuse at baseline.Enrolled patients (N?=?716) were 18-73 years old and most were female (n?=?607, 84.8%). At baseline, patients reported an average 22.0 (SD?=?4.8) headache days per month. 52.1% of patients (n?=?373) completed the study. By 60 and 108 weeks, a significant reduction in headache days (-?9.2 days and -?10.7 days, respectively, P?
SUBMITTER: Blumenfeld AM
PROVIDER: S-EPMC5799088 | biostudies-literature | 2018 Feb
REPOSITORIES: biostudies-literature
ACCESS DATA