Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
XCiDaBLE
Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
1 other identifier
observational
688
1 country
70
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Typical duration for all trials
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 10, 2015
April 1, 2015
2.2 years
January 28, 2011
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of injection patterns and techniques
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.
Two treatment cycles (approximately 6 months/subject)
Secondary Outcomes (1)
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)
Study Arms (2)
Cervical Dystonia
The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of cervical dystonia.
Blepharospasm
The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm.
Interventions
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Eligibility 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merz North America, Inc.lead
- Registrat-Mapicollaborator
Study Sites (70)
Site #001052
Cullman, Alabama, 35058, United States
Unknown Facility
Scottsdale, Arizona, 85258, United States
Site # 001974
Tucson, Arizona, 85713, United States
Site #001046
Encinitas, California, 92024, United States
Site # 001822
Fountain Valley, California, 92708, United States
Site # 001852
La Jolla, California, 92037, United States
Merz Investigative Site #001986
Los Angeles, California, 90095, United States
Site # 001924
Los Gatos, California, 95032, United States
Site # 001005
Newport Beach, California, 92663, United States
Site # 001973
Sacramento, California, 95817, United States
Site # 001977
New Haven, Connecticut, 06520, United States
Site # 001901
Washington D.C., District of Columbia, 20007, United States
Site # 001803
Boca Raton, Florida, 33486, United States
Site # 001805
North Palm Beach, Florida, 33408, United States
Site # 001955
Sarasota, Florida, 34239, United States
Site # 001823
St. Petersburg, Florida, 33713, United States
Site # 001972
Chicago, Illinois, 60611, United States
Site #001057
Glenview, Illinois, 60026, United States
Site #001978
Lake Bluff, Illinois, 60044, United States
Site # 001820
Winfield, Illinois, 60190, United States
Site # 001995
Munster, Indiana, 46321, United States
Site # 001833
Overland Park, Kansas, 66211, United States
Site # 001047
Baton Rouge, Louisiana, 70810, United States
Site # 001849
Baltimore, Maryland, 21287, United States
Site # 001053
Boston, Massachusetts, 02114, United States
Site # 001816
Roseville, Michigan, 48066, United States
Site # 001848
Warren, Michigan, 48088, United States
Site # 001028
Bloomington, Minnesota, 55431, United States
Site # 001834
Eagan, Minnesota, 55122, United States
Site # 001957
Minneapolis, Minnesota, 55455, United States
Site # 001802
Des Peres, Missouri, 63131, United States
Site # 001838
St Louis, Missouri, 63141, United States
Site # 001010
Las Vegas, Nevada, 89102, United States
Site # 001954
Reno, Nevada, 89509, United States
Site #001961
Toms River, New Jersey, 08755, United States
Site # 001860
Kingston, New York, 12401, United States
Site # 001041
New York, New York, 10003, United States
Site # 001921
New York, New York, 10011, United States
Site # 001910
New York, New York, 10029, United States
Site # 001034
North Syracuse, New York, 13212, United States
Site # 001013
Syracuse, New York, 13210, United States
Site # 001951
Durham, North Carolina, 27710, United States
Merz Investigative Site # 001840
Bellevue, Ohio, 44811, United States
Site # 001812
Cleveland, Ohio, 44195, United States
Site # 001826
Columbus, Ohio, 43215, United States
Site # 001815
Tulsa, Oklahoma, 74136, United States
Site # 001916
Bend, Oregon, 97701, United States
Site # 001839
Medford, Oregon, 97504, United States
Site #001000
Collegeville, Pennsylvania, 19426, United States
Site # 001959
Philadelphia, Pennsylvania, 19107, United States
Site #001032
Wynnewood, Pennsylvania, 19096, United States
Site # 001893
Spartanburg, South Carolina, 29303, United States
Site # 001922
Chattanooga, Tennessee, 37411, United States
Site # 001889
Columbia, Tennessee, 38401, United States
Site # 001831
Memphis, Tennessee, 38163, United States
Site # 001836
Nashville, Tennessee, 37203, United States
Merz Investigative Site # 001055
Bedford, Texas, 76021, United States
Site # 001055
Bedford, Texas, 76021, United States
Site # 001037
Bedford, Texas, 76022, United States
Site # 001817
Dallas, Texas, 75214, United States
Site # 001809
Dallas, Texas, 75231, United States
Site # 001022
Houston, Texas, 77030, United States
Site # 001813
Houston, Texas, 77030, United States
Site #001802
Houston, Texas, 77030, United States
Site # 001960
Tyler, Texas, 75701, United States
Site # 001962
Alexandria, Virginia, 22311, United States
Site # 001980
Fishersville, Virginia, 22939, United States
Site #001979
Virginia Beach, Virginia, 23454, United States
Site # 001881
Kirkland, Washington, 98034, United States
Site # 001800
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hubert H. Fernandez, MD, FAAN
Center for Neurological Restoration
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2011
First Posted
February 1, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
April 10, 2015
Record last verified: 2015-04