Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
- Conditions
- Cervical DystoniaBlepharospasm
- Registration Number
- NCT01287247
- Lead Sponsor
- Merz North America, Inc.
- 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®
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 688
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (69)
Site #001052
🇺🇸Cullman, Alabama, 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
Scroll for more (59 remaining)Site #001052🇺🇸Cullman, Alabama, United States