Clinical Trial: Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
Brief Summary: This is a prospective, observational trial evaluating the "real world" use of Xeomin®(incobotulinumtoxinA). Physicians may enroll patients who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical experience. The physician must have chosen to treat the patient with Xeomin® (incobotulinumtoxinA) prior to and independent of enrollment in this study. Physicians may choose to treat their subjects with up to 2 treatment cycles (approximately 6 months/subject) of Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin. According and dependent on clinical practice, the investigators expect that subjects will be seen by the investigator for an average of 3 visits (two treatment cycles).
Detailed Summary:
The primary objective of this trial is to collect, evaluate, and report observational data about the clinical use of Xeomin® in a "real world" setting to determine which muscles are injected, the dose used, and how doctors administer the injection.
The secondary objectives of this trial are: To collect and evaluate information about the efficacy of Xeomin®. To collect and evaluate information about the effect of Xeomin® on work productivity and quality of life. To monitor for any serious side effects and non-serious related side effects of Xeomin®
Sponsor: Merz Pharmaceuticals, LLC
Current Primary Outcome: Determination of injection patterns and techniques [ Time Frame: Two treatment cycles (approximately 6 months/subject) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To collect and evaluate efficacy of Xeomin®(incobotulinumtoxinA) including onset and offset of effect as well as improvement of disease specific and global illness severity [ Time Frame: Two treatment cycles (approximately 6 months/subject) ]
Original Secondary Outcome: Same as current
Information By: Merz Pharmaceuticals, LLC
Dates:
Date Received: January 28, 2011
Date Started: February 2011
Date Completion:
Last Updated: April 9, 2015
Last Verified: April 2015