- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287247
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
Study Overview
Status
Conditions
Intervention / Treatment
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®
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Cullman, Alabama, United States, 35058
- Site #001052
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Arizona
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Scottsdale, Arizona, United States, 85258
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Tucson, Arizona, United States, 85713
- Site # 001974
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California
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Encinitas, California, United States, 92024
- Site #001046
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Fountain Valley, California, United States, 92708
- Site # 001822
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La Jolla, California, United States, 92037
- Site # 001852
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Los Angeles, California, United States, 90095
- Merz Investigative Site #001986
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Los Gatos, California, United States, 95032
- Site # 001924
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Newport Beach, California, United States, 92663
- Site # 001005
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Sacramento, California, United States, 95817
- Site # 001973
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Connecticut
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New Haven, Connecticut, United States, 06520
- Site # 001977
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Site # 001901
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Florida
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Boca Raton, Florida, United States, 33486
- Site # 001803
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North Palm Beach, Florida, United States, 33408
- Site # 001805
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Saint Petersburg, Florida, United States, 33713
- Site # 001823
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Sarasota, Florida, United States, 34239
- Site # 001955
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Illinois
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Chicago, Illinois, United States, 60611
- Site # 001972
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Glenview, Illinois, United States, 60026
- Site #001057
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Lake Bluff, Illinois, United States, 60044
- Site #001978
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Winfield, Illinois, United States, 60190
- Site # 001820
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Indiana
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Munster, Indiana, United States, 46321
- Site # 001995
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Kansas
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Overland Park, Kansas, United States, 66211
- Site # 001833
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Louisiana
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Baton Rouge, Louisiana, United States, 70810
- Site # 001047
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Maryland
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Baltimore, Maryland, United States, 21287
- Site # 001849
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Site # 001053
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Michigan
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Roseville, Michigan, United States, 48066
- Site # 001816
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Warren, Michigan, United States, 48088
- Site # 001848
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Minnesota
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Bloomington, Minnesota, United States, 55431
- Site # 001028
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Eagan, Minnesota, United States, 55122
- Site # 001834
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Minneapolis, Minnesota, United States, 55455
- Site # 001957
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Missouri
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Des Peres, Missouri, United States, 63131
- Site # 001802
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St. Louis, Missouri, United States, 63141
- Site # 001838
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Nevada
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Las Vegas, Nevada, United States, 89102
- Site # 001010
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Reno, Nevada, United States, 89509
- Site # 001954
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New Jersey
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Toms River, New Jersey, United States, 08755
- Site #001961
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New York
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Kingston, New York, United States, 12401
- Site # 001860
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New York, New York, United States, 10003
- Site # 001041
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New York, New York, United States, 10011
- Site # 001921
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New York, New York, United States, 10029
- Site # 001910
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North Syracuse, New York, United States, 13212
- Site # 001034
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Syracuse, New York, United States, 13210
- Site # 001013
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North Carolina
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Durham, North Carolina, United States, 27710
- Site # 001951
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Ohio
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Bellevue, Ohio, United States, 44811
- Merz Investigative Site # 001840
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Cleveland, Ohio, United States, 44195
- Site # 001812
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Columbus, Ohio, United States, 43215
- Site # 001826
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Site # 001815
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Oregon
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Bend, Oregon, United States, 97701
- Site # 001916
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Medford, Oregon, United States, 97504
- Site # 001839
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Pennsylvania
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Collegeville, Pennsylvania, United States, 19426
- Site #001000
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Philadelphia, Pennsylvania, United States, 19107
- Site # 001959
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Wynnewood, Pennsylvania, United States, 19096
- Site #001032
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South Carolina
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Spartanburg, South Carolina, United States, 29303
- Site # 001893
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Tennessee
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Chattanooga, Tennessee, United States, 37411
- Site # 001922
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Columbia, Tennessee, United States, 38401
- Site # 001889
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Memphis, Tennessee, United States, 38163
- Site # 001831
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Nashville, Tennessee, United States, 37203
- Site # 001836
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Texas
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Bedford, Texas, United States, 76021
- Merz Investigative Site # 001055
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Bedford, Texas, United States, 76021
- Site # 001055
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Bedford, Texas, United States, 76022
- Site # 001037
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Dallas, Texas, United States, 75214
- Site # 001817
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Dallas, Texas, United States, 75231
- Site # 001809
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Houston, Texas, United States, 77030
- Site # 001022
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Houston, Texas, United States, 77030
- Site # 001813
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Houston, Texas, United States, 77030
- Site #001802
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Tyler, Texas, United States, 75701
- Site # 001960
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Virginia
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Alexandria, Virginia, United States, 22311
- Site # 001962
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Fishersville, Virginia, United States, 22939
- Site # 001980
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Virginia Beach, Virginia, United States, 23454
- Site #001979
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Washington
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Kirkland, Washington, United States, 98034
- Site # 001881
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Spokane, Washington, United States, 99204
- Site # 001800
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Other Names:
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Blepharospasm
The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm.
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Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Determination of injection patterns and techniques
Time Frame: Two treatment cycles (approximately 6 months/subject)
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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.
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Two treatment cycles (approximately 6 months/subject)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
Time Frame: Two treatment cycles (approximately 6 months/subject)
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Two treatment cycles (approximately 6 months/subject)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hubert H. Fernandez, MD, FAAN, Center for Neurological Restoration
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Movement Disorders
- Dyskinesias
- Eyelid Diseases
- Dystonia
- Dystonic Disorders
- Torticollis
- Blepharospasm
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- incobotulinumtoxinA
Other Study ID Numbers
- MRZ 60201-4066-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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