Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]
Completed
- Conditions
- Cervical Dystonia
- Registration Number
- NCT01840462
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in Tsui scores Baseline and 12 weeks post-injection Cycle 4 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.