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

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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
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Wynnewood, PA
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Alexandria, VA
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Arlington Heights, Illinois 60004
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Bellevue, Ohio 44811
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Beverly Hills, California 90212
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Collegeville, Pennsylvania 19426
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