Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
Status: | Completed |
---|---|
Conditions: | Neurology, Orthopedic, Women's Studies |
Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | February 2011 |
End Date: | February 2013 |
Contact: | Micki Seoane |
Email: | mseoane@merzusa.com |
Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
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®
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.
We found this trial at
90
sites
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