Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States (XCiDaBLE)

April 9, 2015 updated by: Merz North America, Inc.

Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States

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).

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

688

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Cullman, Alabama, United States, 35058
        • Site #001052
    • Arizona
      • Scottsdale, Arizona, United States, 85258
      • Tucson, Arizona, United States, 85713
        • Site # 001974
    • California
      • Encinitas, California, United States, 92024
        • Site #001046
      • Fountain Valley, California, United States, 92708
        • Site # 001822
      • La Jolla, California, United States, 92037
        • Site # 001852
      • Los Angeles, California, United States, 90095
        • Merz Investigative Site #001986
      • Los Gatos, California, United States, 95032
        • Site # 001924
      • Newport Beach, California, United States, 92663
        • Site # 001005
      • Sacramento, California, United States, 95817
        • Site # 001973
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Site # 001977
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Site # 001901
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Site # 001803
      • North Palm Beach, Florida, United States, 33408
        • Site # 001805
      • Saint Petersburg, Florida, United States, 33713
        • Site # 001823
      • Sarasota, Florida, United States, 34239
        • Site # 001955
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Site # 001972
      • Glenview, Illinois, United States, 60026
        • Site #001057
      • Lake Bluff, Illinois, United States, 60044
        • Site #001978
      • Winfield, Illinois, United States, 60190
        • Site # 001820
    • Indiana
      • Munster, Indiana, United States, 46321
        • Site # 001995
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Site # 001833
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810
        • Site # 001047
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Site # 001849
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Site # 001053
    • Michigan
      • Roseville, Michigan, United States, 48066
        • Site # 001816
      • Warren, Michigan, United States, 48088
        • Site # 001848
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Site # 001028
      • Eagan, Minnesota, United States, 55122
        • Site # 001834
      • Minneapolis, Minnesota, United States, 55455
        • Site # 001957
    • Missouri
      • Des Peres, Missouri, United States, 63131
        • Site # 001802
      • St. Louis, Missouri, United States, 63141
        • Site # 001838
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Site # 001010
      • Reno, Nevada, United States, 89509
        • Site # 001954
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Site #001961
    • New York
      • Kingston, New York, United States, 12401
        • Site # 001860
      • New York, New York, United States, 10003
        • Site # 001041
      • New York, New York, United States, 10011
        • Site # 001921
      • New York, New York, United States, 10029
        • Site # 001910
      • North Syracuse, New York, United States, 13212
        • Site # 001034
      • Syracuse, New York, United States, 13210
        • Site # 001013
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Site # 001951
    • Ohio
      • Bellevue, Ohio, United States, 44811
        • Merz Investigative Site # 001840
      • Cleveland, Ohio, United States, 44195
        • Site # 001812
      • Columbus, Ohio, United States, 43215
        • Site # 001826
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Site # 001815
    • Oregon
      • Bend, Oregon, United States, 97701
        • Site # 001916
      • Medford, Oregon, United States, 97504
        • Site # 001839
    • Pennsylvania
      • Collegeville, Pennsylvania, United States, 19426
        • Site #001000
      • Philadelphia, Pennsylvania, United States, 19107
        • Site # 001959
      • Wynnewood, Pennsylvania, United States, 19096
        • Site #001032
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Site # 001893
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Site # 001922
      • Columbia, Tennessee, United States, 38401
        • Site # 001889
      • Memphis, Tennessee, United States, 38163
        • Site # 001831
      • Nashville, Tennessee, United States, 37203
        • Site # 001836
    • Texas
      • Bedford, Texas, United States, 76021
        • Merz Investigative Site # 001055
      • Bedford, Texas, United States, 76021
        • Site # 001055
      • Bedford, Texas, United States, 76022
        • Site # 001037
      • Dallas, Texas, United States, 75214
        • Site # 001817
      • Dallas, Texas, United States, 75231
        • Site # 001809
      • Houston, Texas, United States, 77030
        • Site # 001022
      • Houston, Texas, United States, 77030
        • Site # 001813
      • Houston, Texas, United States, 77030
        • Site #001802
      • Tyler, Texas, United States, 75701
        • Site # 001960
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Site # 001962
      • Fishersville, Virginia, United States, 22939
        • Site # 001980
      • Virginia Beach, Virginia, United States, 23454
        • Site #001979
    • Washington
      • Kirkland, Washington, United States, 98034
        • Site # 001881
      • Spokane, Washington, United States, 99204
        • Site # 001800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Other Names:
  • botulinum toxin
  • incobotulinumtoxinA
Blepharospasm
The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm.
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Other Names:
  • botulinum toxin
  • incobotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of injection patterns and techniques
Time Frame: 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.
Two treatment cycles (approximately 6 months/subject)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Two treatment cycles (approximately 6 months/subject)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Hubert H. Fernandez, MD, FAAN, Center for Neurological Restoration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (ESTIMATE)

February 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

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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