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

Cervical Dystonia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245958
• Other study ID #: GMA-US-NEU-0271
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2014
• Last updated: January 6, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• 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: 44
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• 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 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

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

Mexico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of Botulinum Toxin Used to Treat Cervical Dystonia		4 Years	No
Primary	Dose of Botulinum Toxin Used to Treat Blepharospasm		4 Years	No
Secondary	Botulinum Toxin Inter-injection Intervals		4 Years	No
Secondary	Number of Participants with Adverse Events		4 Years	No
Secondary	Annual Botulinum Toxin Dose per Patient		4 Years	No