Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
- Conditions
- Cervical DystoniaBlepharospasm
- Interventions
- Biological: Xeomin®
- 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
- Arm && Interventions
Group Intervention Description Cervical Dystonia Xeomin® The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of cervical dystonia. Blepharospasm Xeomin® The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm.
- 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 #001979
🇺🇸Virginia Beach, Virginia, United States
Merz Investigative Site #001986
🇺🇸Los Angeles, California, United States
Site # 001972
🇺🇸Chicago, Illinois, United States
Site # 001813
🇺🇸Houston, Texas, United States
Site #001802
🇺🇸Houston, Texas, United States
Site # 001957
🇺🇸Minneapolis, Minnesota, United States
Site # 001951
🇺🇸Durham, North Carolina, United States
Site #001052
🇺🇸Cullman, Alabama, United States
Site #001046
🇺🇸Encinitas, California, United States
Site # 001974
🇺🇸Tucson, Arizona, United States
Site # 001852
🇺🇸La Jolla, California, United States
Site # 001924
🇺🇸Los Gatos, California, United States
Site # 001005
🇺🇸Newport Beach, California, United States
Site # 001901
🇺🇸Washington, District of Columbia, United States
Site # 001803
🇺🇸Boca Raton, Florida, United States
Site # 001805
🇺🇸North Palm Beach, Florida, United States
Site # 001823
🇺🇸Saint Petersburg, Florida, United States
Site # 001955
🇺🇸Sarasota, Florida, United States
Site #001057
🇺🇸Glenview, Illinois, United States
Site # 001820
🇺🇸Winfield, Illinois, United States
Site # 001833
🇺🇸Overland Park, Kansas, United States
Site # 001047
🇺🇸Baton Rouge, Louisiana, United States
Site # 001849
🇺🇸Baltimore, Maryland, United States
Site # 001816
🇺🇸Roseville, Michigan, United States
Site # 001053
🇺🇸Boston, Massachusetts, United States
Site # 001848
🇺🇸Warren, Michigan, United States
Site # 001834
🇺🇸Eagan, Minnesota, United States
Site # 001010
🇺🇸Las Vegas, Nevada, United States
Site # 001838
🇺🇸St. Louis, Missouri, United States
Site # 001954
🇺🇸Reno, Nevada, United States
Site #001961
🇺🇸Toms River, New Jersey, United States
Site # 001860
🇺🇸Kingston, New York, United States
Site # 001910
🇺🇸New York, New York, United States
Site # 001041
🇺🇸New York, New York, United States
Site # 001921
🇺🇸New York, New York, United States
Site # 001034
🇺🇸North Syracuse, New York, United States
Site # 001812
🇺🇸Cleveland, Ohio, United States
Merz Investigative Site # 001840
🇺🇸Bellevue, Ohio, United States
Site # 001826
🇺🇸Columbus, Ohio, United States
Site # 001916
🇺🇸Bend, Oregon, United States
Site # 001839
🇺🇸Medford, Oregon, United States
Site # 001959
🇺🇸Philadelphia, Pennsylvania, United States
Site # 001893
🇺🇸Spartanburg, South Carolina, United States
Site #001000
🇺🇸Collegeville, Pennsylvania, United States
Site # 001922
🇺🇸Chattanooga, Tennessee, United States
Site # 001889
🇺🇸Columbia, Tennessee, United States
Site # 001836
🇺🇸Nashville, Tennessee, United States
Site # 001831
🇺🇸Memphis, Tennessee, United States
Merz Investigative Site # 001055
🇺🇸Bedford, Texas, United States
Site # 001055
🇺🇸Bedford, Texas, United States
Site # 001817
🇺🇸Dallas, Texas, United States
Site # 001037
🇺🇸Bedford, Texas, United States
Site # 001809
🇺🇸Dallas, Texas, United States
Site # 001022
🇺🇸Houston, Texas, United States
Site # 001960
🇺🇸Tyler, Texas, United States
Site # 001962
🇺🇸Alexandria, Virginia, United States
Site # 001980
🇺🇸Fishersville, Virginia, United States
Site # 001881
🇺🇸Kirkland, Washington, United States
Site # 001800
🇺🇸Spokane, Washington, United States
Site # 001815
🇺🇸Tulsa, Oklahoma, United States
Site # 001028
🇺🇸Bloomington, Minnesota, United States
Site # 001013
🇺🇸Syracuse, New York, United States
Site # 001822
🇺🇸Fountain Valley, California, United States
Site #001978
🇺🇸Lake Bluff, Illinois, United States
Site #001032
🇺🇸Wynnewood, Pennsylvania, United States
Site # 001995
🇺🇸Munster, Indiana, United States
Site # 001802
🇺🇸Des Peres, Missouri, United States
Site # 001973
🇺🇸Sacramento, California, United States
Site # 001977
🇺🇸New Haven, Connecticut, United States