A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA
Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)
1 other identifier
observational
62
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2012
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 31, 2012
CompletedFirst Posted
Study publicly available on registry
August 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 30, 2017
March 1, 2017
4.6 years
July 31, 2012
March 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
Baseline, 96 Weeks
Secondary Outcomes (4)
Patient's Global Impression of Change (PGIC) Using a 7-Point Scale
Baseline, 96 Weeks
Work Productivity Assessment Using a 10-Item Questionnaire
96 Weeks
Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score
Baseline, 96 Weeks
Reasons for Withdrawal of Treatment
96 Weeks
Study Arms (1)
OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Interventions
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Eligibility Criteria
Patients with Cervical Dystonia (Dystonie)
You may qualify if:
- Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (8)
Clinique Neuro-Rive Sud
Greenfield Park, Quebec, J4V 2J2, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Chum-Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Queen Elizabeth Health Centre: Medical Specialist Clinic
Montreal, Quebec, H4A 3L5, Canada
CHU de Québec, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Centre Medical Le Mesnil
Québec, Quebec, G2K 0H1, Canada
Polyclinique Medicale des Ponts
Saint Romuald, Quebec, G6W 8H1, Canada
CHU - Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Goran Davidovic
Allergan
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
August 2, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
March 30, 2017
Record last verified: 2017-03