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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Xeomin®
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.
Biological: Xeomin®
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merz North America, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Registrat-Mapi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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