title: Prospective Study Evaluating IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm: Interim Results from the First 145 Subjects with Cervical Dystonia.
abstract: BACKGROUND
  We report the interim results from XCiDaBLE, a large, prospective, observational "naturalistic" study evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or BLEpharospasm in the United States.
  
  
  METHODS
  Subjects (≥ 18 years old) with cervical dystonia (CD) are followed for two treatment cycles and monitored via Interactive Voice/Web Response. The subject's physician must have chosen to treat with incobotulinumtoxinA prior to and independent of enrollment in this study. Subject-reported scales include the Subject Global Impression-Severity and Improvement and Cervical Dystonia Impact Profile (CDIP-58), and Work Productivity and Quality of Life (QoL) are assessed by means of an employment questionnaire and work history and the SF-12v2 Health Survey (SF-12v2). Subjects are seen by the investigator for three visits, which include a baseline visit (including the first injection), a second injection visit, and a final study visit (12 weeks after the second injection).
  
  
  RESULTS
  This ongoing study includes 145 subjects with a diagnosis of CD. The majority were female (82.3%) and white (91.0%) and had previously been treated with botulinum toxins (77.2%). There were 106 employed at the time of disease onset, but 12.6 years later only 44% were still employed at the time of enrolment into the study, and 20% were either receiving or seeking disability benefits. The mean total dose/treatment of CD was 225.2 units for the first injection. The CDIP-58 total score was significantly improved 4 weeks after the first injection compared to baseline (p≤0.0001). Most subjects noted improvement in their global impression assessment. No new or unexpected adverse events occurred.
  
  
  CONCLUSIONS
  The results from these interim analyses confirm previous controlled, single-dose studies of incobotulinumtoxinA in terms of efficacy and safety.
authors.affiliation: Cleveland Clinic, Cleveland, Ohio, United States of America.
authors.forename: Hubert H
authors.initials: HH
authors.lastname: Fernandez
authors.forename: Fernando
authors.initials: F
authors.lastname: Pagan
authors.forename: Fabio
authors.initials: F
authors.lastname: Danisi
authors.forename: David
authors.initials: D
authors.lastname: Greeley
authors.forename: Joseph
authors.initials: J
authors.lastname: Jankovic
authors.forename: Amit
authors.initials: A
authors.lastname: Verma
authors.forename: Kapil
authors.initials: K
authors.lastname: Sethi
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Pappert
keywords: CDIP-58; NT 201; botulinum toxin type A; cervical dystonia; incobotulinumtoxinA