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Completed

NCT Number: NCT01655862

A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA

This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.

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Key information

Conditions

Torticollis Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Neuro-Rive Sud, Greenfield Park, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician

Exclusion criteria

  • Participation in a clinical trial for any botulinum toxin indication
  • Planning elective surgery during the observational study period
  • Treatment with any botulinum toxin product for cervical dystonia (dystonie)
  • Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start

Treatment and study plan

onabotulinumtoxinA

Biological

OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.

Other names: botulinum toxin Type A, BOTOX®

Primary outcomes

  1. Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score

    Time frame: Baseline, 96 Weeks

Secondary outcomes

  1. Patient's Global Impression of Change (PGIC) Using a 7-Point Scale

    Time frame: Baseline, 96 Weeks

  2. Work Productivity Assessment Using a 10-Item Questionnaire

    Time frame: 96 Weeks

  3. Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score

    Time frame: Baseline, 96 Weeks

  4. Reasons for Withdrawal of Treatment

    Time frame: 96 Weeks

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2012
Registry last updated
Mar 30, 2017

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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