Blepharospasm, Cervical Dystonia
Conditions
Keywords
Cervical dystonia, Blepharospasm
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 description
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®
Interventions
BIOLOGICALXeomin®
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Sponsors
Registrat-Mapi
Merz North America, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years of age or older. * The physician must have chosen to treat the patient with Xeomin® (incobotulinumtoxinA) prior to and independent of enrollment in this study. * Subjects who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon the physicians' clinical experience. There are no restrictive subject entry criteria. * Subjects who are able to read, speak and understand English.
Exclusion criteria
* Subjects who are enrolled in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol are not eligible for this trial. * Any subject for whom botulinum toxin treatment would be contraindicated; see Xeomin® Prescribing Information for further details.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of injection patterns and techniques | Two treatment cycles (approximately 6 months/subject) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Two treatment cycles (approximately 6 months/subject) |
Countries
United States
Outcome results
None listed