Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]

Study Overview
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Brief Summary
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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.

Official Title
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A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)

Conditions
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Cervical Dystonia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects naïve to botulinum toxin A (BoNT-A) treatment<br>Patients naïve to botulinum toxin A treatment | |
| Subjects pre-treated with botulinum toxin A (BoNT-A) injection<br>Patients pre-treated with botulinum toxin A for at least 2 years. 4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tsui scores | 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. | Baseline and 12 weeks post-injection Cycle 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tsui scores | 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. | Baseline and 12 weeks post-injection Cycle 1 | 
| Change in Tsui scores | 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. | Baseline and 12 weeks post-injection Cycle 3 | 
| Change in Tsui scores | 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. | Baseline and 12 weeks post-injection Cycle 4 |