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

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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

March 18, 2013
March 20, 2013
June 4, 2014
July 3, 2014
July 3, 2014
January 2013
July 2013   (Final data collection date for primary outcome measure)
  • 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.
  • 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 ]
Complete list of historical versions of study NCT01814774 on ClinicalTrials.gov Archive Site
  • 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.
Number of Participants With Adverse Events [ Time Frame: 1 Year ]
Not Provided
Not Provided
 
A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm
Not Provided
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
  • Cervical Dystonia
  • Blepharospasm
Other: No Intervention
No treatment (intervention) was administered.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
90
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway,   United Kingdom
 
 
NCT01814774
TRU2011
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
June 2014