Prospective Study Evaluating IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm: Interim Results from the First 145 Subjects with Cervical Dystonia

Prospective Study Evaluating IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm: Interim Results from the First 145 Subjects with Cervical Dystonia

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Background: We report the interim results from XCiDaBLE: truvisionhealthftp.com A large prospective, observational "naturalistic" study evaluating Xeomin® (incobotulinumtoxinA) for cervical dystonia or blepharospasm in the United States.Methods: Subjects with CD are followed for 2 treatment cycles and monitored via Interactive Voice/Web Response.Subject-reported scales include the Subject Global Impression-Severity and Improvement; 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.

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 onset of the disease, 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.However, only 44% were still employed at the time of recruitment for study participation.The mean total dose/treatment of CD was 225.

2 units for the 1st injection.The CDIP-58 total score was significantly improved at four weeks post the napoleon concealer first injection compared to baseline (p=<0.0001).

Most subjects noted improvement in their global impression assessment.No new or unexpected adverse events occurred.Discussion: The results from these interim analyses confirm previous controlled single-dose studies of incobotulinumtoxinA in terms of efficacy and safety.