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

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Brief Title

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

Official Title

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

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).
    

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


Primary Outcome

Determination of injection patterns and techniques

Secondary Outcome

 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

Condition

Cervical Dystonia

Intervention

Xeomin®

Study Arms / Comparison Groups

 Cervical Dystonia
Description:  The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of cervical dystonia.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

688

Start Date

February 2011

Completion Date

April 2013

Primary Completion Date

April 2013

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hubert H. Fernandez, MD, FAAN, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01287247

Organization ID

MRZ 60201-4066-5


Responsible Party

Sponsor

Study Sponsor

Merz North America, Inc.

Collaborators

 Registrat-Mapi

Study Sponsor

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


Verification Date

April 2015