Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01287247
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : April 10, 2015
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Cervical Dystonia Blepharospasm Biological: Xeomin®

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®


Layout table for study information
Study Type : Observational
Actual Enrollment : 688 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
Study Start Date : February 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013


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.
Biological: Xeomin®
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Other Names:
  • incobotulinumtoxinA
  • botulinum toxin

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:
  • incobotulinumtoxinA
  • botulinum toxin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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 [ Time Frame: Two treatment cycles (approximately 6 months/subject) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287247


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

Layout table for additonal information
Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01287247     History of Changes
Other Study ID Numbers: MRZ 60201-4066-5
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Merz North America, Inc.:
Cervical dystonia
Blepharospasm
Additional relevant MeSH terms:
Layout table for MeSH terms
Dystonia
Dystonic Disorders
Torticollis
Blepharospasm
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Eyelid Diseases
Eye Diseases
Botulinum Toxins
incobotulinumtoxinA
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents