• Neurology · Oct 2011

    Randomized Controlled Trial Multicenter Study

    OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine.

    • R B Lipton, S F Varon, B Grosberg, P J McAllister, F Freitag, S K Aurora, D W Dodick, S D Silberstein, H C Diener, R E DeGryse, M E Nolan, and C C Turkel.
    • Albert Einstein College of Medicine, Bronx, NY 10461, USA. Richard.lipton@einstein.yu.edu
    • Neurology. 2011 Oct 11;77(15):1465-72.

    ObjectiveTo assess the effects of treatment with onabotulinumtoxinA (Botox, Allergan, Inc., Irvine, CA) on health-related quality of life (HRQoL) and headache impact in adults with chronic migraine (CM).MethodsThe Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program (PREEMPT 1 and 2) included a 24-week, double-blind phase (2 12-week cycles) followed by a 32-week, open-label phase (3 cycles). Thirty-one injections of 5U each (155 U of onabotulinumtoxinA or placebo) were administered to fixed sites. An additional 40 U could be administered "following the pain." Prespecified analysis of headache impact (Headache Impact Test [HIT]-6) and HRQoL (Migraine-Specific Quality of Life Questionnaire v2.1 [MSQ]) assessments were performed. Because the studies were similar in design and did not notably differ in outcome, pooled results are presented here.ResultsA total of 1,384 subjects were included in the pooled analyses (onabotulinumtoxinA, n = 688; placebo, n = 696). Baseline mean total HIT-6 and MSQ v2.1 scores were comparable between groups; 93.1% were severely impacted based on HIT-6 scores ≥60. At 24 weeks, in comparison with placebo, onabotulinumtoxinA treatment significantly reduced HIT-6 scores and the proportion of patients with HIT-6 scores in the severe range at all timepoints including week 24 (p < 0.001). OnabotulinumtoxinA treatment significantly improved all domains of the MSQ v2.1 at 24 weeks (p < 0.001).ConclusionsTreatment of CM with onabotulinumtoxinA is associated with significant and clinically meaningful reductions in headache impact and improvements in HRQoL.Classification Of EvidenceThis study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.

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