- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01814774
A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm
June 4, 2014 updated by: Allergan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bergen, Norway
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Wakefield, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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BOTOX®
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice.
No treatment (intervention) was administered.
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No treatment (intervention) was administered.
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Xeomin®
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice.
No treatment (intervention) was administered.
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No treatment (intervention) was administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose of Botulinum Toxin Used to Treat Cervical Dystonia
Time Frame: 2 Years
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The average dose of botulinum toxin received per patient per year was calculated.
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2 Years
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Dose of Botulinum Toxin Used to Treat Blepharospasm
Time Frame: 2 Years
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The average dose of botulinum toxin received per patient per year was calculated.
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2 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Adverse Events
Time Frame: 2 Years
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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.
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2 Years
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Botulinum Toxin Inter-injection Interval
Time Frame: 2 Years
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Injection-interval was the time in weeks between injections of botulinum toxin.
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2 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
March 18, 2013
First Submitted That Met QC Criteria
March 18, 2013
First Posted (Estimate)
March 20, 2013
Study Record Updates
Last Update Posted (Estimate)
July 3, 2014
Last Update Submitted That Met QC Criteria
June 4, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRU2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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