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

Cervical Dystonia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814774
• Other study ID #: TRU2011
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: June 4, 2014
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardNorway: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blepharospasm
• Cervical Dystonia
• Dystonia
• Dystonic Disorders

Intervention

Other:
• No Intervention
No treatment (intervention) was administered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of Botulinum Toxin Used to Treat Cervical Dystonia	The average dose of botulinum toxin received per patient per year was calculated.	2 Years	No
Primary	Dose of Botulinum Toxin Used to Treat Blepharospasm	The average dose of botulinum toxin received per patient per year was calculated.	2 Years	No
Secondary	Number of Participants With Adverse Events	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.	2 Years	No
Secondary	Botulinum Toxin Inter-injection Interval	Injection-interval was the time in weeks between injections of botulinum toxin.	2 Years	No