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

NCT ID: NCT01287247

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

688 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-04-30

Brief Summary

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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).

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Detailed Description

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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®

Conditions

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Cervical Dystonia Blepharospasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Xeomin®

Intervention Type BIOLOGICAL

Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with 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.

Xeomin®

Intervention Type BIOLOGICAL

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

Interventions

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Xeomin®

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

Intervention Type BIOLOGICAL

Other Intervention Names

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incobotulinumtoxinA botulinum toxin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Registrat-Mapi

OTHER

Sponsor Role collaborator

Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hubert H. Fernandez, MD, FAAN

Role: PRINCIPAL_INVESTIGATOR

Center for Neurological Restoration

Locations

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Site #001052

Cullman, Alabama, United States

Site Status

Scottsdale, Arizona, United States

Site Status

Site # 001974

Tucson, Arizona, United States

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Site #001046

Encinitas, California, United States

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Site # 001822

Fountain Valley, California, United States

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Site # 001852

La Jolla, California, United States

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Merz Investigative Site #001986

Los Angeles, California, United States

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Site # 001924

Los Gatos, California, United States

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Site # 001005

Newport Beach, California, United States

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Site # 001973

Sacramento, California, United States

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Site # 001977

New Haven, Connecticut, United States

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Site # 001901

Washington D.C., District of Columbia, United States

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Site # 001803

Boca Raton, Florida, United States

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Site # 001805

North Palm Beach, Florida, United States

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Site # 001955

Sarasota, Florida, United States

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Site # 001823

St. Petersburg, Florida, United States

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Site # 001972

Chicago, Illinois, United States

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Site #001057

Glenview, Illinois, United States

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Site #001978

Lake Bluff, Illinois, United States

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Site # 001820

Winfield, Illinois, United States

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Site # 001995

Munster, Indiana, United States

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Site # 001833

Overland Park, Kansas, United States

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Site # 001047

Baton Rouge, Louisiana, United States

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Site # 001849

Baltimore, Maryland, United States

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Site # 001053

Boston, Massachusetts, United States

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Site # 001816

Roseville, Michigan, United States

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Site # 001848

Warren, Michigan, United States

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Site # 001028

Bloomington, Minnesota, United States

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Site # 001834

Eagan, Minnesota, United States

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Site # 001957

Minneapolis, Minnesota, United States

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Site # 001802

Des Peres, Missouri, United States

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Site # 001838

St Louis, Missouri, United States

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Site # 001010

Las Vegas, Nevada, United States

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Site # 001954

Reno, Nevada, United States

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Site #001961

Toms River, New Jersey, United States

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Site # 001860

Kingston, New York, United States

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Site # 001041

New York, New York, United States

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Site # 001921

New York, New York, United States

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Site # 001910

New York, New York, United States

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Site # 001034

North Syracuse, New York, United States

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Site # 001013

Syracuse, New York, United States

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Site # 001951

Durham, North Carolina, United States

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Merz Investigative Site # 001840

Bellevue, Ohio, United States

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Site # 001812

Cleveland, Ohio, United States

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Site # 001826

Columbus, Ohio, United States

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Site # 001815

Tulsa, Oklahoma, United States

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Site # 001916

Bend, Oregon, United States

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Site # 001839

Medford, Oregon, United States

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Site #001000

Collegeville, Pennsylvania, United States

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Site # 001959

Philadelphia, Pennsylvania, United States

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Site #001032

Wynnewood, Pennsylvania, United States

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Site # 001893

Spartanburg, South Carolina, United States

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Site # 001922

Chattanooga, Tennessee, United States

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Site # 001889

Columbia, Tennessee, United States

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Site # 001831

Memphis, Tennessee, United States

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Site # 001836

Nashville, Tennessee, United States

Site Status

Merz Investigative Site # 001055

Bedford, Texas, United States

Site Status

Site # 001055

Bedford, Texas, United States

Site Status

Site # 001037

Bedford, Texas, United States

Site Status

Site # 001817

Dallas, Texas, United States

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Site # 001809

Dallas, Texas, United States

Site Status

Site # 001022

Houston, Texas, United States

Site Status

Site # 001813

Houston, Texas, United States

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Site #001802

Houston, Texas, United States

Site Status

Site # 001960

Tyler, Texas, United States

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Site # 001962

Alexandria, Virginia, United States

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Site # 001980

Fishersville, Virginia, United States

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Site #001979

Virginia Beach, Virginia, United States

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Site # 001881

Kirkland, Washington, United States

Site Status

Site # 001800

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MRZ 60201-4066-5

Identifier Type: -

Identifier Source: org_study_id

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