Torticollis
Conditions
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.
Interventions
BIOLOGICALOnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score | Baseline, 96 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed