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OpenTrials
Completed

NCT Number: NCT01814774

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No treatment (intervention) was administered.

Primary outcomes

  1. Dose of Botulinum Toxin Used to Treat Cervical Dystonia

    Time frame: 2 Years

    The average dose of botulinum toxin received per patient per year was calculated.

  2. Dose of Botulinum Toxin Used to Treat Blepharospasm

    Time frame: 2 Years

    The average dose of botulinum toxin received per patient per year was calculated.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 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.

  2. Botulinum Toxin Inter-injection Interval

    Time frame: 2 Years

    Injection-interval was the time in weeks between injections of botulinum toxin.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2013
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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