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

NCT02245958 | Completed

• 1 other identifier: GMA-US-NEU-0271
• Study Type: observational
• Target: 44
• Locations: 2 countries
• Sites: 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.

Conditions

Cervical Dystonia; Blepharospasm

Outcome Measures

Primary Outcomes (2)

• Dose of Botulinum Toxin Used to Treat Cervical Dystonia

  4 Years

• Dose of Botulinum Toxin Used to Treat Blepharospasm

  4 Years

Secondary Outcomes (3)

• Botulinum Toxin Inter-injection Intervals

  4 Years

• Number of Participants with Adverse Events

  4 Years

• Annual Botulinum Toxin Dose per Patient

  4 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.

Other: No Intervention

Xeomin®

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

Other: No Intervention

Interventions

No Intervention OTHER

No treatment (intervention) was administered.

BOTOX®; Xeomin®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX® in clinical practice.

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 2 years 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Colonia Roma Z.P., 06700, Mexico

Location

Unknown Facility

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Torticollis; Blepharospasm

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eyelid Diseases; Eye Diseases

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 22, 2014
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

ME (1); GB (1)