Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
Completed
Conditions studied: Cervical Dystonia, Blepharospasm
In brief
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).
Key facts
- Study ID
- NCT01287247
- Run by
- Merz North America, Inc.
- People needed
- 688
- Starts
- 2011-02-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2015-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — 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 — 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
- Site # 001977 — New Haven, Connecticut, United States
- Site # 001901 — Washington D.C., District of Columbia, United States
- Site # 001803 — Boca Raton, Florida, United States
- Site # 001805 — North Palm Beach, Florida, United States
- Site # 001955 — Sarasota, Florida, United States
- Site # 001823 — St. Petersburg, Florida, United States
- Site # 001972 — Chicago, Illinois, United States
- Site #001057 — Glenview, Illinois, United States
- Site #001978 — Lake Bluff, Illinois, United States
- Site # 001820 — Winfield, Illinois, United States
- Site # 001995 — Munster, Indiana, United States
- Site # 001833 — Overland Park, Kansas, United States
- Site # 001047 — Baton Rouge, Louisiana, United States
- Site # 001849 — Baltimore, Maryland, United States
- Site # 001053 — Boston, Massachusetts, United States
- Site #001052 — Cullman, Alabama, United States
Full record on ClinicalTrials.gov
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