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

Sponsor
Merz North America, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01287247
Collaborator
Registrat-Mapi (Other)
688
Enrollment
70
Locations
26
Duration (Months)
9.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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®

Study Design

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 :
Feb 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determination of injection patterns and techniques [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 [Two treatment cycles (approximately 6 months/subject)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site #001052 Cullman Alabama United States 35058
    2 Scottsdale Arizona United States 85258
    3 Site # 001974 Tucson Arizona United States 85713
    4 Site #001046 Encinitas California United States 92024
    5 Site # 001822 Fountain Valley California United States 92708
    6 Site # 001852 La Jolla California United States 92037
    7 Merz Investigative Site #001986 Los Angeles California United States 90095
    8 Site # 001924 Los Gatos California United States 95032
    9 Site # 001005 Newport Beach California United States 92663
    10 Site # 001973 Sacramento California United States 95817
    11 Site # 001977 New Haven Connecticut United States 06520
    12 Site # 001901 Washington District of Columbia United States 20007
    13 Site # 001803 Boca Raton Florida United States 33486
    14 Site # 001805 North Palm Beach Florida United States 33408
    15 Site # 001823 Saint Petersburg Florida United States 33713
    16 Site # 001955 Sarasota Florida United States 34239
    17 Site # 001972 Chicago Illinois United States 60611
    18 Site #001057 Glenview Illinois United States 60026
    19 Site #001978 Lake Bluff Illinois United States 60044
    20 Site # 001820 Winfield Illinois United States 60190
    21 Site # 001995 Munster Indiana United States 46321
    22 Site # 001833 Overland Park Kansas United States 66211
    23 Site # 001047 Baton Rouge Louisiana United States 70810
    24 Site # 001849 Baltimore Maryland United States 21287
    25 Site # 001053 Boston Massachusetts United States 02114
    26 Site # 001816 Roseville Michigan United States 48066
    27 Site # 001848 Warren Michigan United States 48088
    28 Site # 001028 Bloomington Minnesota United States 55431
    29 Site # 001834 Eagan Minnesota United States 55122
    30 Site # 001957 Minneapolis Minnesota United States 55455
    31 Site # 001802 Des Peres Missouri United States 63131
    32 Site # 001838 St. Louis Missouri United States 63141
    33 Site # 001010 Las Vegas Nevada United States 89102
    34 Site # 001954 Reno Nevada United States 89509
    35 Site #001961 Toms River New Jersey United States 08755
    36 Site # 001860 Kingston New York United States 12401
    37 Site # 001041 New York New York United States 10003
    38 Site # 001921 New York New York United States 10011
    39 Site # 001910 New York New York United States 10029
    40 Site # 001034 North Syracuse New York United States 13212
    41 Site # 001013 Syracuse New York United States 13210
    42 Site # 001951 Durham North Carolina United States 27710
    43 Merz Investigative Site # 001840 Bellevue Ohio United States 44811
    44 Site # 001812 Cleveland Ohio United States 44195
    45 Site # 001826 Columbus Ohio United States 43215
    46 Site # 001815 Tulsa Oklahoma United States 74136
    47 Site # 001916 Bend Oregon United States 97701
    48 Site # 001839 Medford Oregon United States 97504
    49 Site #001000 Collegeville Pennsylvania United States 19426
    50 Site # 001959 Philadelphia Pennsylvania United States 19107
    51 Site #001032 Wynnewood Pennsylvania United States 19096
    52 Site # 001893 Spartanburg South Carolina United States 29303
    53 Site # 001922 Chattanooga Tennessee United States 37411
    54 Site # 001889 Columbia Tennessee United States 38401
    55 Site # 001831 Memphis Tennessee United States 38163
    56 Site # 001836 Nashville Tennessee United States 37203
    57 Merz Investigative Site # 001055 Bedford Texas United States 76021
    58 Site # 001055 Bedford Texas United States 76021
    59 Site # 001037 Bedford Texas United States 76022
    60 Site # 001817 Dallas Texas United States 75214
    61 Site # 001809 Dallas Texas United States 75231
    62 Site # 001022 Houston Texas United States 77030
    63 Site # 001813 Houston Texas United States 77030
    64 Site #001802 Houston Texas United States 77030
    65 Site # 001960 Tyler Texas United States 75701
    66 Site # 001962 Alexandria Virginia United States 22311
    67 Site # 001980 Fishersville Virginia United States 22939
    68 Site #001979 Virginia Beach Virginia United States 23454
    69 Site # 001881 Kirkland Washington United States 98034
    70 Site # 001800 Spokane Washington United States 99204

    Sponsors and Collaborators

    • Merz North America, Inc.
    • Registrat-Mapi

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merz North America, Inc.
    ClinicalTrials.gov Identifier:
    NCT01287247
    Other Study ID Numbers:
    • MRZ 60201-4066-5
    First Posted:
    Feb 1, 2011
    Last Update Posted:
    Apr 10, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Merz North America, Inc.
    Cervical dystonia
    Blepharospasm
    Additional relevant MeSH terms:
    Dystonia
    Dystonic Disorders
    Blepharospasm
    Torticollis
    Botulinum Toxins
    incobotulinumtoxinA

    Study Results

    No Results Posted as of Apr 10, 2015