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

Completed

• Conditions: Blepharospasm; Cervical Dystonia
• Interventions: Other: No Intervention

• Registration Number: NCT01814774
• 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 Start: 2013-01
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-06
• Results First Submitted: 2014-06-04
• Results First Submitted QC: 2014-06-04
• Last Update Submitted: 2014-06-04
• Results First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BOTOX®	No Intervention	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Xeomin®	No Intervention	Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.

Primary Outcome Measures

Name	Time	Method
Dose of Botulinum Toxin Used to Treat Blepharospasm	2 Years	The average dose of botulinum toxin received per patient per year was calculated.
Dose of Botulinum Toxin Used to Treat Cervical Dystonia	2 Years	The average dose of botulinum toxin received per patient per year was calculated.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	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	2 Years	Injection-interval was the time in weeks between injections of botulinum toxin.