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

Completed

• Conditions: Cervical Dystonia; Blepharospasm

• Registration Number: NCT02245958
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Study Start: 2015-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
• Treatment with Xeomin® and BOTOX® for at least 2 years 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose of Botulinum Toxin Used to Treat Cervical Dystonia	4 Years
Dose of Botulinum Toxin Used to Treat Blepharospasm	4 Years

Secondary Outcome Measures

Name	Time	Method
Botulinum Toxin Inter-injection Intervals	4 Years
Number of Participants with Adverse Events	4 Years
Annual Botulinum Toxin Dose per Patient	4 Years