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CompletedNCT02245958Updated Jan 8, 2016

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

An observational study in Cervical Dystonia and Blepharospasm, sponsored by Allergan. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-08.

Sponsored by Allergan (part of AbbVie) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
44
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cervical Dystonia
  • Blepharospasm
03

In context

Torticollis

121 studies on the registry are indexed under Torticollis; 18 are open to participants now.

This study's enrollment of 44 is close to the median of 48 across 43 observational studies indexed under Torticollis.

Browse Torticollis studies →

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo Intervention

    No treatment (intervention) was administered.

06

What researchers measure

Primary outcomes

  1. Dose of Botulinum Toxin Used to Treat Cervical Dystonia

    Time frame: 4 Years

  2. Dose of Botulinum Toxin Used to Treat Blepharospasm

    Time frame: 4 Years

Secondary outcomes

  1. Botulinum Toxin Inter-injection Intervals

    Time frame: 4 Years

  2. Number of Participants with Adverse Events

    Time frame: 4 Years

  3. Annual Botulinum Toxin Dose per Patient

    Time frame: 4 Years

07

Study locations

2 sites
  • Colonia Roma Z.P., 06700, Mexico
  • Wakefield, WF1 4DG, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02245958
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Sep 22, 2014
Start date
Aug 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 8, 2016

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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