Cervical Dystonia
Conditions
Brief summary
The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component * Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion * With the intention to be treated with Dysport®
Exclusion criteria
* The subject has already been included in this study * Participation in an interventional trial * Suffering from anterocollis or retrocollis as primary component
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tsui scores | Baseline and 12 weeks post-injection Cycle 2 | The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tsui scores | Baseline and 12 weeks post-injection Cycle 1 | The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner. |
Countries
Austria, Germany
Outcome results
None listed