title: OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine.
abstract: 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.
  
  
  METHODS
  This study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.
authors.affiliation: Albert Einstein College of Medicine, Bronx, NY 10461, USA. Richard.lipton@einstein.yu.edu
authors.forename: R B
authors.initials: RB
authors.lastname: Lipton
authors.forename: S F
authors.initials: SF
authors.lastname: Varon
authors.forename: B
authors.initials: B
authors.lastname: Grosberg
authors.forename: P J
authors.initials: PJ
authors.lastname: McAllister
authors.forename: F
authors.initials: F
authors.lastname: Freitag
authors.forename: S K
authors.initials: SK
authors.lastname: Aurora
authors.forename: D W
authors.initials: DW
authors.lastname: Dodick
authors.forename: S D
authors.initials: SD
authors.lastname: Silberstein
authors.forename: H C
authors.initials: HC
authors.lastname: Diener
authors.forename: R E
authors.initials: RE
authors.lastname: DeGryse
authors.forename: M E
authors.initials: ME
authors.lastname: Nolan
authors.forename: C C
authors.initials: CC
authors.lastname: Turkel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000523:psychology*; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D010147:Pain Measurement; D011581:Psychological Tests; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A