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A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm

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: NCT01814774
Recruitment Status : Completed
First Posted : March 20, 2013
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date March 18, 2013
First Posted Date March 20, 2013
Results First Submitted Date June 4, 2014
Results First Posted Date July 3, 2014
Last Update Posted Date July 3, 2014
Study Start Date January 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2014)
  • Dose of Botulinum Toxin Used to Treat Cervical Dystonia [ Time Frame: 2 Years ]
    The average dose of botulinum toxin received per patient per year was calculated.
  • Dose of Botulinum Toxin Used to Treat Blepharospasm [ Time Frame: 2 Years ]
    The average dose of botulinum toxin received per patient per year was calculated.
Original Primary Outcome Measures
 (submitted: March 18, 2013)
  • Dose of Botulinum Toxin Used to Treat Cervical Dystonia [ Time Frame: 1 Year ]
  • Dose of Botulinum Toxin Used to Treat Blepharospasm [ Time Frame: 1 Year ]
Change History Complete list of historical versions of study NCT01814774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 4, 2014)
  • Number of Participants With Adverse Events [ Time Frame: 2 Years ]
    An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.
  • Botulinum Toxin Inter-injection Interval [ Time Frame: 2 Years ]
    Injection-interval was the time in weeks between injections of botulinum toxin.
Original Secondary Outcome Measures
 (submitted: March 18, 2013)
Number of Participants With Adverse Events [ Time Frame: 1 Year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm
Official Title Not Provided
Brief Summary This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
Condition
  • Cervical Dystonia
  • Blepharospasm
Intervention Other: No Intervention
No treatment (intervention) was administered.
Study Groups/Cohorts
  • BOTOX®
    Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
    Intervention: Other: No Intervention
  • Xeomin®
    Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
    Intervention: Other: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 4, 2013)
48
Original Estimated Enrollment
 (submitted: March 18, 2013)
90
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
  • treatment with Xeomin® and BOTOX® for at least 1 year each

Exclusion Criteria:

  • having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
  • previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01814774
Other Study ID Numbers TRU2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date June 2014