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

March 28, 2017 updated by: Allergan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 1Z4
        • CHU de Québec, Hôpital de l'Enfant-Jésus
      • Quebec, Canada, G2K 0H1
        • Centre Medical Le Mesnil
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Clinique Neuro-Rive Sud
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H2L 4M1
        • Chum-Notre-Dame
      • Montreal, Quebec, Canada, H4A 3L5
        • Queen Elizabeth Health Centre: Medical Specialist Clinic
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHU - Sherbrooke
      • St-Romuald, Quebec, Canada, G6W 8H1
        • Polyclinique Medicale des Ponts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Cervical Dystonia (Dystonie)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
Time Frame: Baseline, 96 Weeks
Baseline, 96 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's Global Impression of Change (PGIC) Using a 7-Point Scale
Time Frame: Baseline, 96 Weeks
Baseline, 96 Weeks
Work Productivity Assessment Using a 10-Item Questionnaire
Time Frame: 96 Weeks
96 Weeks
Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score
Time Frame: Baseline, 96 Weeks
Baseline, 96 Weeks
Reasons for Withdrawal of Treatment
Time Frame: 96 Weeks
96 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Goran Davidovic, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMA-BTX-12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Torticollis

Clinical Trials on OnabotulinumtoxinA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe