OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine

Neurology. 2011 Oct 11;77(15):1465-72. doi: 10.1212/WNL.0b013e318232ab65. Epub 2011 Sep 28.


Objective: To 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).

Methods: The 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.

Results: A 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).

Conclusions: Treatment of CM with onabotulinumtoxinA is associated with significant and clinically meaningful reductions in headache impact and improvements in HRQoL.

Classification of evidence: This study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Botulinum Toxins, Type A / therapeutic use*
  • Chronic Disease
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • International Cooperation
  • Male
  • Middle Aged
  • Migraine Disorders / drug therapy*
  • Migraine Disorders / psychology*
  • Neuromuscular Agents / therapeutic use*
  • Pain Measurement
  • Psychological Tests
  • Quality of Life*
  • Treatment Outcome
  • Young Adult


  • Neuromuscular Agents
  • Botulinum Toxins, Type A