Idiopathic Cervical Dystonia
Conditions
Brief summary
A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Idiopathic cervical dystonia * TWSTRS severity score ≥ 15 * At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion * Written informed consent prior to collect the data
Exclusion criteria
* Contraindications to any BoNT-A preparations * Secondary cervical dystonia * Subject already been included in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice | Around 4 weeks post injection |
Secondary
| Measure | Time frame |
|---|---|
| To identify prognostic factors for response (Exploratory Objective) | baseline, and around 4 weeks and 3 months post injection |
| To describe TWSTRS change scores from inclusion (total score & subscales scores) | Baseline, and around 4 weeks and 3 months post injection |
| To describe tremor change score from inclusion (TSUI scale) | Baseline, and around 4 weeks and 3 months post injection |
| To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion | Baseline, and around 4 weeks post injection |
| To describe subject and investigator's CGI scores | Around 4 weeks post injection |
Countries
Australia, Belgium, Czechia, France, Germany, Netherlands, Portugal, Russia, United Kingdom
Outcome results
None listed