A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm
1 other identifier
observational
48
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2013
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
July 3, 2014
CompletedJuly 3, 2014
June 1, 2014
6 months
March 18, 2013
June 4, 2014
June 4, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Dose of Botulinum Toxin Used to Treat Cervical Dystonia
The average dose of botulinum toxin received per patient per year was calculated.
2 Years
Dose of Botulinum Toxin Used to Treat Blepharospasm
The average dose of botulinum toxin received per patient per year was calculated.
2 Years
Secondary Outcomes (2)
Number of Participants With Adverse Events
2 Years
Botulinum Toxin Inter-injection Interval
2 Years
Study Arms (2)
BOTOX®
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Xeomin®
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Interventions
Eligibility Criteria
Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (2)
Unknown Facility
Bergen, Norway
Unknown Facility
Wakefield, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2013
First Posted
March 20, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 3, 2014
Results First Posted
July 3, 2014
Record last verified: 2014-06