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).
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®
Study Type
OBSERVATIONAL
Enrollment
688
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Site #001052
Cullman, Alabama, United States
Unnamed facility
Scottsdale, Arizona, United States
Site # 001974
Tucson, Arizona, United States
Site #001046
Encinitas, California, United States
Site # 001822
Fountain Valley, California, United States
Site # 001852
Determination of injection patterns and techniques
To collect, evaluate and report observational data about the clinical use of Xeomin® in a "real world" setting to determine injection patterns and use of guidance techniques.
Time frame: Two treatment cycles (approximately 6 months/subject)
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)
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La Jolla, California, United States
Merz Investigative Site #001986
Los Angeles, California, United States
Site # 001924
Los Gatos, California, United States
Site # 001005
Newport Beach, California, United States
Site # 001973
Sacramento, California, United States
...and 60 more locations